An eye mask for use with respiratory pressure therapy

Abstract

The technology relates to an eye mask used with a respiratory pressure therapy (RPT) system, comprising an eye component positionable over orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface, a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user, a positioning and stabilising structure configured to provide a force to hold the eye component of the eye mask in an in-use position on a user's head and a connection structure configured to directly or indirectly fluidly connect with an air circuit of a respiratory therapy system or component thereof. Also described is a patient interface for use with an RPT system, the patient interface incorporating said eye mask.

Description

AN EYE MASK1 BACKGROUND OF THE TECHNOLOGY1.1 FIELD OF THE TECHNOLOGY

[0001] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to an eye mask for use with a respiratory therapy system.1.2 DESCRIPTION OF THE RELATED ART1.2.1 Human Respiratory System and its Disorders

[0002] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0003] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “ Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0005] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0006] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper airpassage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem, e.g. see US Patent No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload, e.g. see US Patent No. 6,532,959 (Berthon- Jones).

[0008] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient’s needs. Respiratory failure may encompass some or all of the following disorders.

[0009] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0010] Obesity Hypoventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0011] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking(primary risk factor), occupational exposures, air pollution and genetic factors.Symptoms include: dyspnea on exertion, chronic cough and sputum production.

[0012] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders:Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0013] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

[0014] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.1.2.2 Therapies

[0015] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV),and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.

[0016] Respiratory pressure therapies

[0017] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0018] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0019] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient breathing and / or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0020] Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.1.2.2.1 Flow therapies

[0021] Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, by delivering an inspiratory flow rate profile over a targeted duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to thepatient’s airways is ‘open’ (unsealed) and the respiratory therapy may only supplement the patient’s own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow therapy (HFT) is the provision of a continuous, heated, humidified flow of air to an entrance to the airway through an unsealed or open patient interface at a “treatment flow rate” that may be held approximately constant throughout the respiratory cycle. The treatment flow rate is nominally set to exceed the patient’s peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway entrance improves ventilation efficiency by flushing, or washing out, expired CO2 from the patient’s anatomical deadspace. Hence, HFT is thus sometimes referred to as a deadspace therapy (DST). Other benefits may include the elevated warmth and humidification (possibly of benefit in secretion management) and the potential for modest elevation of airway pressures. As an alternative to constant flow rate, the treatment flow rate may follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors may prescribe a continuous flow of oxygen enriched air at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) at a specified flow rate (e.g., 1 litre per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient’s airway.1.2.2.2 Respiratory Therapy Systems

[0023] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0024] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.1.2.2.3 Patient Interface

[0025] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and / or mouth, a tube to the mouth or atracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH20. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.

[0026] Certain mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.

[0027] Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.

[0028] Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.

[0029] Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.

[0030] Certain masks may cause some patients a feeling of claustrophobia, unease and / or may feel overly obtrusive.

[0031] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.

[0032] Consequently, some masks suffer from being obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and / or uncomfortable especially when worn for long or when a patient is unfamiliar with a system. Wrongly sizedmasks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy, especially if the mask is to be worn during sleep.

[0033] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0034] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0035] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.

[0036] Sleep is an important component to an individual's wellbeing, growth and vitality. It is also important in today's overstimulated and highly stressed world. In particular, maintaining the wholeness and wholesomeness of the sleep / wake cycle day-to-day and month-to-month is essential to preserve personal well-being and happiness as well as the productivity and good order of society at large. Ideally, the rhythm of the sleep / wake cycle would be governed by the natural order of each day’s sunrise and sunset. The artificial routines of modern personal and social life, however, have eclipsed the rhythms of nature making it more difficult to wake up and go to sleep at appointed times the more the exigencies of one's own routines are in conflict with the natural cycle of things.

[0037] Eye masks with a light-tight design which provides a condition of total darkness are known to help stimulate melatonin production and thus serve to promote a state of sleep. However, current eye masks may be uncomfortable, especially for a side sleeper, or too heavy or cumbersome to use.

[0038] Certain eye masks may be uncomfortable or impractical, for example, if used for prolonged time periods. Certain eye masks can be complicated for users to attach and to correctly position on the head for effective use.

[0039] As a consequence of these challenges, some eye masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and uncomfortable especially when worn for long periods of time or when a user is unfamiliar with a system.

[0040] Respiratory therapies are often delivered while the patient is asleep (or is attempting to sleep). However, many patients find it more difficult to get to sleep while wearing a patient interface.

[0041] Eye masks with a light-blocking design which provides a condition of total darkness are known to help stimulate melatonin production and thus serve to promote a state of sleep, and so use of an eye mask when respiratory therapy is being delivered may assist with helping the patient sleep well during therapy.

[0042] However, many eye masks may be inconvenient to use in combination with a patient interface. For example, placing eye mask straps over a PAP system which uses conduits as a positioning and stabilising structure can lead to crushing of the conduits and consequent air restriction during treatment. Conversely, if the patient places the eye-mask on first, they subsequently have to place their PAP mask system on while partially or fully visually obstructed.

[0043] It would be desirable to overcome or ameliorate at least one of the abovedescribed problems, or at least to provide a useful alternative.1.2.2.4 Seal-forming structure

[0044] Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’s face, the shape and configuration of the seal -forming structure can have a direct impact the effectiveness and comfort of the patient interface.

[0045] A patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use. In oneform of patient interface, a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0046] A seal -forming structure that may be effective in one region of a patient’s face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead may not be appropriate to use on a patient’s nose.

[0047] Certain seal-forming structures may be designed for mass manufacture such that one design is able to fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.

[0048] One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0049] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

[0050] Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.

[0051] Another form of seal-forming structure may use adhesive to achieve a seal.

[0052] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0053] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puri tan -Bennett Corporation.

[0054] ResMed Inc. has manufactured the following products that incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows mask, SWIFTTM LT nasal pillows mask, SWIFTTM FX nasal pillows mask and MIRAGE LIBERTYTM full-face mask. The following patent applications describe examples of nasal pillows masks: International Patent Application WO 2004 / 073778 (describing amongst other things aspects of the SWIFTTM nasal pillows mask), US Patent Application 2009 / 0044808 (describing amongst other things aspects of the SWIFTTM LT nasal pillows mask); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing amongst other things aspects of the MIRAGE LIBERTYTM full-face mask); International Patent Application WO 2009 / 052560 (describing amongst other things aspects of the SWIFTTM FX nasal pillows mask).1.2.2.5 Positioning and Stabilising Structure

[0055] A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and / or claustrophobia when wearing the patient interface; and aesthetic appeal.

[0056] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some.

[0057] Another technique is the use of one or more straps and / or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.

[0058] Rigid elements, also known as "rigidisers", have been used with stretchable headgears previously. One known problem is associated with the fact that a rigidiser permanently attached (e.g. laminated or stitched) to a large area of the stretchable material limits the stretchable length of the material, thus affecting the elastic properties of the entire headgear. Another issue concerns cleaning the headgear which would require both the rigidiser and stretchable material to be washed together as they are permanently attached to each other.1.2.2.6 Pressurised Air Conduit

[0059] In one type of treatment system, a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface at a location that is in front of the patient’s face when the patient interface is positioned on the patient’s face during use, the fluid connection providing a fluid pathway between the patient interface / and the air circuit. The conduit may extend from the patient interface forwards away from the patient’s face.1.2.2.7 Respiratory Pressure Therapy (RPT) Device

[0060] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.1.2.2.8 Air circuit

[0061] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.2 SUMMARY OF THE TECHNOLOGY

[0062] The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0063] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0064] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0065] An aspect of certain forms of the present technology is to provide methods and / or apparatus that improve the compliance of patients with respiratory therapy.

[0066] One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure. The plenum chamber includes at least oneplenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The patient interface also comprises a seal-forming structure that is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares. The seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use. The patient interface also comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0067] Another aspect of one form of the present technology is a series of modular elements that may be interconnected in order to form different styles of patient interfaces.

[0068] In one form, there are at least two versions or styles of each modular element. The versions or styles may be interchangeably used with one another in order to form different modular assemblies.

[0069] An aspect of some forms of the present technology is to provide methods and / or apparatus that improve the compliance of users with respiratory and / or sleep therapy.

[0070] An aspect of some forms of the present technology is to provide methods and / or apparatus that improve the quality of sleep of users.

[0071] Some forms of the present technology are set out below in relation to an eye mask, with the features disclosed below provided in any combination or selection.

[0072] An aspect of some forms of the present technology is to provide methods and / or apparatus that improve the quality of sleep of users when using respiratory therapy.

[0073] An aspect of the present technology is an eye mask. In some forms the eye mask is configured for use with a respiratory pressure therapy (RPT) system. In some forms, the eye mask comprises an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface. In some forms, the eye mask is a component of a patient interface of an RPT system.

[0074] An aspect of the present technology is a patient interface configured for use with a respiratory pressure therapy (RPT) system comprising an eye mask.

[0075] In some forms the eye mask comprises a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user.

[0076] In some forms the eye mask comprises a positioning and stabilising structure configured to provide a force to hold the eye component of the eye mask in an in-use position on the user’s head during use of the eye mask.

[0077] In some forms the eye mask comprises a frame portion configured to be fluidly connectable with an air circuit of a respiratory therapy system or component thereof.

[0078] An aspect of the present technology is an eye mask for use as a patient interface in a respiratory pressure therapy (RPT) system, the eye mask comprising:an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface;a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user;a positioning and stabilising structure configured to provide a force to hold the eye component of the eye mask in an in-use position on the user’s head during use of the eye mask; anda connection structure configured to directly or indirectly connect with a component of a respiratory therapy system.

[0079] In certain forms, the eye mask comprises a face-contacting structure connected to the posterior surface of the eye component, the face-contacting structure comprising a user-facing surface on the user-facing side of the face-contacting structure and the cavity is formed within the user-facing surface of the face contacting structure.In certain forms, the face-contacting structure comprises a recess formed within the user-facing surface, a perimeter of the recess defined or partially defined by a wall extending at least from a base portion of the recess to the user-facing surface.In some forms, the patient interface comprises a functional module removably housed within the recess.

[0080] In certain forms, the perimeter of the cavity is defined or partially defined by a wall extending at least from a base portion of the cavity to the user-facing surface of the face-contacting structure.

[0081] In certain forms, the wall extends around the superior boundaries of the cavity.

[0082] In certain forms, the wall extends around the lateral boundaries of the cavity.

[0083] In certain forms, the wall extends around the inferior boundaries of the cavity.

[0084] In certain forms, the wall extends continuously around the superior , lateral and inferior boundaries of the cavity.

[0085] In certain forms, the wall extends around the superior and lateral boundaries of the cavity and at least partially around the inferior boundary of the cavity.

[0086] In certain forms, the wall comprises a first side wall portion extending from the perimeter of the base portion of the cavity to the user-facing surface of the face-contacting structure, and a second side wall portion opposing and spaced apart from the first side wall portion closer to the perimeter of the eye mask than the first side wall portion and extending towards the user-facing surface, the first and second side wall portions are spanned by a user-facing surface wall portion.

[0087] In certain forms, the second side-wall portion of the wall forms a portion of the perimeter of the eye mask.

[0088] In certain forms the wall comprises a superior raised wall section extending laterally along a superior edge of the cavity, proximate to, or on a top edge of the eye mask.

[0089] In certain forms, the wall comprises an inferior raised wall section extending along or partially along an inferior edge of the cavity, and / or proximate to, or on the inferior edge of the eye mask.

[0090] In certain forms, the superior and inferior raised wall sections are connected by opposing lateral edge wall sections to define a perimeter of the cavity.

[0091] In certain forms, the superior raised wall section comprises a first side wall portion and a second side wall portion opposing the first side wall portion, the first and second side wall portions spanned by a user-facing surface wall portion.

[0092] In certain forms the inferior raised wall section comprises a first side wall portion and a second side wall portion opposing the first side wall portion, the first and second side wall portions spanned by a user-facing surface wall portion.

[0093] In certain forms the superior raised wall section is configured such that the user-facing surface wall portion of the superior raised wall section is a greater distance from a base portion of the cavity than the user-facing surface wall portion of the inferior raised wall section.

[0094] In certain forms, the first side wall portion of the superior raised wall section has a height from the base portion of the cavity to the user-facing surface wall portion of the first side wall portion of 5 - 50mm, specifically 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, 36mm, 37mm, 38mm, 39mm, 40mm, 41mm, 42mm, 43mm, 44mm, 45mm, 46mm, 47mm, 48mm, 49mm, or 50mm.

[0095] In certain forms, the second side wall portion of the superior raised wall section has a height from the eye-component to the user-facing surface wall portion of the second side wall portion of 5mm - 50mm, specifically, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, 36mm, 37mm, 38mm, 39mm, 40mm, 41mm, 42mm, 43mm, 44mm, 45mm, 46mm, 47mm, 48mm, 49mm, or 50mm.

[0096] In certain forms, the user-facing wall portion of the superior raised wall section has a width spanning the first and second side wall portions of the superior raised wall section of 5mm - 100mm. In some forms the width is 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm,34mm, 35mm, 36mm, 37mm, 38mm, 39mm, 40mm, 41mm, 42mm, 43mm, 44mm, 45mm, 46mm, 47mm, 48mm, 49mm or 50mm.

[0097] In certain forms, the superior raised wall section is configured such when the eye mask is in position on a user’s face, the superior-inferior axis of the anterior surface of the eye component 7010 is between 0 - 30° either side of vertical.

[0098] In certain forms, the superior raised wall section is sized to substantially traverse at least between left and right supraorbital foramen and / or span the central region of the frontal bone of a user’s head in use.

[0099] In certain forms, the first side wall portion and / or a second side wall portion of the superior raised wall section are variable in height along the length of the superior raised wall section.

[0100] In certain forms, the first side wall portion and / or a second side wall portion of the inferior raised wall section are variable in height along the length of the inferior raised wall section.

[0101] In certain forms, the superior and inferior raised wall sections are connected by opposing lateral edge wall sections to define a perimeter of the cavity.

[0102] In certain forms, the superior, inferior raised wall sections and the lateral edge sections comprise compressive material for improved light blocking.

[0103] In certain forms, the user-facing surface wall portion and / or facecontacting structure is at least partially formed by, or comprises on an outer surface or portion thereof, a material that promotes friction and / or has a high co-efficient of friction. In some forms, the material is silicon, polished silicon, synthetic polymer or rubber.

[0104] In certain forms, the superior raised wall section and / or lateral edge wall sections are formed by, or comprise on an outer surface or portion thereof, a material that promotes friction and / or has a high co-efficient of friction. In some forms, the material is silicon, polished silicon, synthetic polymer or rubber.

[0105] In some forms, the user-facing surface wall portion of the superior-raised wall section and / or lateral edge wall sections comprises an adhesive suitable for connection to skin such as a hydrogel, double coated tape, hydrocolloid or a pressuresensitive adhesive.

[0106] In certain forms, the recess formed within the user-facing surface of the face-contacting structure is formed superior to the cavity. In some forms the recess is sized to substantially traverse at least between left and right zygomatic regions of a user’s head in use. In some forms the cavity is sized to substantially traverse the orbital regions of a user’s head in use.

[0107] In some forms of the technology the wall extends at least partially around the superior, lateral and inferior boundaries of the cavity and the recess.

[0108] In some forms, the wall comprises a superior raised wall section extending laterally along a top edge of the recess, proximate a top edge of the eye mask, an intermediate raised wall section spaced apart from the superior raised wall section and extending laterally along an inferior edge of the recess / superior edge of the cavity, and an inferior raised wall section extending along a bottom edge of the cavity, proximate the inferior edge of the eye mask.

[0109] In some form, the superior raised wall section is more resiliently flexible than the intermediate or inferior raised wall sections.

[0110] In some forms, the superior raised wall section extends from a base portion of the recess a greater distance than the intermediate raised wall section extends from the base portion of the recess, such that the user-facing surface wall portion of the superior raised wall section abuts the user’s face when the mask is in use.

[0111] In certain forms, the superior and inferior raised wall sections are connected by opposing lateral edge wall sections to define a perimeter of the cavity.

[0112] In certain forms, the superior, inferior raised wall sections and the lateral edge sections comprise compressive material for improved light blocking.

[0113] In one form the functional module comprises a convex side and a concave side, the concave side comprising a user-contacting layer comprising a textile, fabric composite, silicone pad, cushion region, fragrance delivery mechanism, sensor, cooling material, gripping material, massage component, light source or combination thereof.

[0114] In one form the user-contacting layer comprises a moisture-wi eking fabric, anti-bacterial fabric, breathable fabric or combination thereof.

[0115] In one form the user-contacting layer further comprises a conductive material for use as an electrode.

[0116] In one form, the conductive material is conductive silicone or conductive thread.

[0117] In one form the conductive material is incorporated onto the usercontacting layer as one or more shapes or patterns.

[0118] In one form the functional module comprises a first end portion, a second end portion, and a middle portion flanked by the first end portion and the second end portion, wherein a width of the first end portion, second end portion and middle portion are substantially the same.

[0119] In one form the first end portion and second end portions have a rounded edge.

[0120] In one form the concave side of the functional module comprises a foam adjacent to the user-contacting layer.

[0121] In one form the functional module comprises a cavity for housing at least one component, wherein the cavity comprises at least one component-retaining structure for engaging the component.

[0122] In one form the component-retaining structure is selected from a friction fit, snap fit, spring release fit, magnetic coupling, or a combination thereof.

[0123] In one form the user-contacting layer comprises a window for exposing a portion of the component.

[0124] In one form, the functional module comprises a connector for engaging with a complementary connector in or on the recess of the eye mask.

[0125] In one form the connector may be any one or more of a mechanical connection, hook and / or loop material, friction fit connection, press-fit studs, conductive fasteners, spring release engagement, textile pockets or male / female connectors or combination thereof.

[0126] In one form the connector may be one or more magnets. In some forms the connector comprises two magnets with reverse polarity.

[0127] In one form the functional module houses at least one of the following components selected from a sensor component, noise reduction component, pivot component, cooling component, imaging component, massage component, visual component, audio component, charging component, and power supply.

[0128] In one form the sensor component is selected from a electroencephalography (EEG) sensor, a photoplethysmography (PPG) sensor, electromyography (EMG) sensor, electrooculography (EOG) sensor, a pulse oximeter (SpO2) sensor, respiratory rate (RR) sensor, heart rate (HR) sensor, and a heart rate variability (HRV) sensor.

[0129] In one form, the functional module further comprises a magnetic charging port configured to engage with a magnetic cover.

[0130] In one form the functional module has a depth representing the distance between the concave side and the convex side of the functional module, the depth of the functional module being greater than the distance between the base of the recess and the user-facing surface wall portion of the wall around the perimeter of the recess.

[0131] In certain forms, the functional module has a depth of 5mm - 100mm. In some forms the depth is 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, 36mm, 37mm, 38mm, 39mm, 40mm, 41mm, 42mm, 43mm, 44mm, 45mm, 46mm, 47mm, 48mm, 49mm or 50mm.

[0132] In certain forms, functional module is configured such when the eye mask is in position on a user’s face and the functional module is held within the recess of the eye mask, the superior-inferior axis of the anterior surface of the eye component is between 0 - 30° either side of vertical.

[0133] In certain forms, the functional module is sized to substantially traverse at least between left and right supraorbital foramen and / or span the central region of the frontal bone of a user’s head in use.

[0134] In certain forms, the depth of the functional module is variable. In some forms the depth of the functional module in the medial region of the functional module is greater than the depth of the functional module at the lateral regions of the functional module.

[0135] In certain forms, the perimeter of eye mask is shaped to include a bridge portion in the form of a curved wall along the inferior edge or part thereof of the eye mask. In some forms, the inferior raised wall section, face contacting structure and / or eye component curves around the anterior / posterior axis of the eye mask forming a nasal curve in the eye mask to accommodate the nasal bridge of a user.

[0136] In some forms the inferior raised wall section, face contacting structure and / or eye component that curves around the anterior / posterior axis of the eye mask defines an open space for accommodating the nose of the user or part thereof, the eye mask further comprising a cover member configured to span the open space, covering the user’ s nose or part thereof.

[0137] In certain forms the cover member is in the form of a flexible textile or foam component.

[0138] In some forms, the cover member is formed by the eye component.

[0139] In some forms, the cover member is releasably connectable to an anterior surface of the eye component of the eye mask.

[0140] In some forms of the present technology, the nasal curve is formed by curving the eye-component material such that it forms a parabola.

[0141] In one form, the bridge portion comprises a portion of the inferior raised wall section.

[0142] In some forms, the inferior raised wall section comprises at least one compressive region defined by the first side wall portion, second side wall portion, user-facing surface wall portion of the wall and a posterior surface of the eye component.

[0143] In some forms, the at least one compressive region comprises at least one air-pocket.

[0144] In some forms, the inferior raised wall section comprises at least one compressible or deformable member encased by the first side wall portion, second side wall portion, user-facing surface wall portion and the posterior surface of the eye component.

[0145] In some forms, the at least one compressible or deformable member is an open cell foam, closed cell foam, low density foam, memory foam, gel or beads.

[0146] In some forms, the inferior raised wall section is formed from a compressible material to provide a comfortable engagement and light blocking around the nasal and / or cheek region.

[0147] In some forms, the connection structure is integrally formed with the eye mask.

[0148] In some forms, the connection structure is configured to be removably connectable to the eye mask.

[0149] In some forms, the connection structure is connected or connectable to an inferior edge of the eye mask.

[0150] In some forms, the connection structure is connected or connectable to the inferior raised wall section of the eye mask.

[0151] In some forms the connection structure is overmolded with the eye component of the eye mask.

[0152] In some forms the connection structure is overmolded with the facecontacting structure of the eye mask.

[0153] In some forms, the connection structure comprises a frame portion, the frame portion configured to be fluidly connectable with an air circuit of a respiratory therapy system of component thereof.

[0154] In some forms, the frame portion comprises a frame body.

[0155] In some forms, the frame portion comprises at least one rigi diser arm.

[0156] In some forms the frame portion comprises a frame body and two rigi diser arms symmetrically disposed on opposite sides of the frame body.

[0157] In some forms, the connection structure comprises at least one elongate sleeve. In some forms the sleeve is configured as a hollow tube defining an elongate sleeve cavity. In some forms the tube has at least one opening. In some forms the sleeve defines an opening at a first end. In some forms, the sleeve defines an opening at a first end and an opposing second end. In some forms the sleeve is formed from textile or foam.

[0158] In some forms the connection structure comprises two elongate sleeves formed at an inferior edge of the eye mask and / or wall. In some forms the two elongate sleeves are formed within, in, or by the face contacting structure and / or eye component of the eye mask; wherein each elongate sleeve forms an at least one opening to receive at least a portion of at least one arm of the frame portion within the elongate sleeve cavity.

[0159] In some forms each elongate sleeve comprises two openings, at least one opening in the form of a buttonhole or slit. In some forms at least one opening is formed in a wall of the hollow tube.

[0160] In some forms the eye mask comprises a bridge portion configured as a curved wall centrally positioned along an inferior edge or part thereof of the eye mask and one each of the two elongate sleeves are located on opposing sides of the bridge portion.

[0161] In some forms the inferior raised wall section comprises two raised wall sections spaced apart along the inferior edge of the eye mask either side of the bridge portion. In some forms, each raised wall section comprises therein, or is formed as, an elongate sleeve.

[0162] In some forms the at least one opening is formed in each elongate sleeve proximate the bridge portion of the eye mask. In some forms, two openings are formed in each elongate sleeve. In some forms at least one opening is the opening of the sleeve configured to enable receipt of a length of the rigidiser arm within the sleeve cavity. In some forms at least one opening is configured to releasably connect the rigidiser arm to the elongate sleeve.

[0163] In some forms the two elongate sleeves are configured to releasably receive the rigidiser arms of the frame portion.In some forms the two elongate sleeves are each continuously formed with a portion of the positioning and stabilising structure of the eye mask.In some forms the at least one elongate sleeve may be made of an elastic textile material and the elongate sleeve may be arranged such that the at least one elongate sleeve is substantially free to move by elastically expanding and / or contracting, relative to the at least one rigidiser arm.

[0164] In some forms, the eye component has an overall curvature such that the anterior surface of the eye component is substantially convex and the posterior surface of the eye component is substantially concave.

[0165] In some forms the face-contacting structure has an overall curvature complementing the substantially concave posterior surface of the eye component.

[0166] In some forms the recesses and walls of the eye mask comprise / are formed from a shaped eye component and a complementary shaped face-contacting structure. In other forms, the recesses and walls comprise / are formed from a shaped face-contacting structure.

[0167] In some forms the face-contacting structure comprises a thermoformed textile.

[0168] In some forms, the wall of the face-contacting structure comprises foam, thermoformed textile or compressive material.

[0169] In some forms the eye component comprises a textile and / or foam.

[0170] In some forms, the eye component comprises a laminate of textile and foam. In some forms the laminate may be thermoformed.

[0171] In some forms the eye component comprises a laminate of textile and foam and is formed such that the first anterior surface of the eye component comprises a textile and the opposing inner surface of the eye component comprises a foam.

[0172] In some forms, the eye component comprises a textile layer on the anterior surface of the eye component, the textile layer connected to a periphery or edge of the eye component and / or face-contacting structure.

[0173] In some forms, the textile layer is not connected to the anterior surface of the eye component.

[0174] In certain forms, the textile layer is a stretchable textile such as a knit fabric or stretchable non-woven. In some forms the stretchable fabric is a two-way or four-way stretch fabric.

[0175] In some forms, the eye component or parts thereof are compressible.

[0176] In some forms, the face-contacting structure or parts thereof are compressible.

[0177] In some forms, the eye component may differ in density, compressibility, elasticity, resilience or stiffness at different regions of the eye component.

[0178] In some forms, the face-contacting structure may differ in density, compressibility, elasticity, flexibility, resilience or stiffness at different regions of the face-contacting structure.

[0179] In some forms, the user-facing surface of the face-contacting structure 7020 is compressible.

[0180] In other forms, the wall of the face-contacting structure encloses at least one air pocket.

[0181] In some forms the eye component and face-contacting structure are connected together at a seam or connecting edge and the seam or connecting edge is not positioned on the user-facing surface of the face-contacting structure. In some forms the seam of connecting edge is formed on the first or second side wall portion of the wall to prevent contact with the user’s face.

[0182] An aspect of the present technology is a patient interface for use with a respiratory pressure therapy (RPT) system comprising:an eye mask comprising;an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface;a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user;a connection structure comprising a frame portion configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof; anda positioning and stabilising structure constructed and arranged to provide an elastic force to hold the eye component of the eye mask in an in-use position on theuser’s head and to hold the frame portion in therapeutically effective position on the patient’s head during use of RPT system.

[0183] In some forms, the patient interface comprises a cushion assembly, wherein the cushion assembly comprises a seal forming structure configured to removably connect to the frame portion of the eye mask, the seal forming structure constructed and arranged to form a seal with a region of the patient’s face at or surrounding an entrance to the patient’s airways such that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient’s nares, the seal forming structure constructed and arranged to maintain said therapeutic pressure in the frame portion throughout the patient’s respiratory cycle in use.In some forms the frame body and cushion assembly together form a plenum chamber and each configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof; the plenum chamber at least partially forming a cavity pressurisable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient.

[0184] In some forms, the cushion assembly is a nasal pillows mask, nasal cradle mask or nasal mask for delivery of a supply of pressurised air or breathable gas to an entrance of a patient's airways. The cushion assembly may comprise: a retaining structure for repeatable engagement with and disengagement from a frame member; and a seal -forming structure permanently connected to the retaining structure; wherein an increase in air pressure within the cushion member causes a sealing force between the seal-forming structure and the frame member to increase; and wherein a retention force between the retaining structure and the frame member is higher than a disengagement force to disengage the retaining structure from the frame member.

[0185] In some forms the patient interface comprises a component of an air circuit selected from an air conduit or an air conduit connection portion.In some forms, the frame portion comprises a frame body and two or more rigidiser arms symmetrically disposed on opposite sides of the frame body; and

[0186] In some forms, each of the rigi diser arms comprises a distal free end distal from the frame body, and a proximate attached end proximate the frame body, each of the rigidiser arms comprising a protrusion at the proximate end of each rigidiser arm, the protrusion configured to releasably connect to a component of the connection structure of the eye mask.

[0187] In some forms the connection structure comprises at least one sleeve formed by, on or within the eye component and / or positioning and stabilising structure of the of the patient interface.

[0188] In some forms the connection structure further comprises two elongate sleeves formed at, with or on an inferior edge of the eye mask, each elongate sleeve forming at least one opening to receive at least a portion of one of the two or more rigidiser arms of the frame portion.

[0189] In some forms each at least one of the openings is formed as a slit or buttonhole configured to releasably receive a protrusion on the rigidiser arm and secure the rigidiser arm in position within the elongate sleeve.

[0190] In some forms the eye mask comprises a bridge portion configured as a curved wall centrally positioned along an inferior edge or part thereof of the eye mask and one of each of the two elongate sleeves are located either side of the bridge portion.

[0191] In some forms, the opening is formed in an end of each elongate sleeve proximate the bridge portion of the eye mask.

[0192] In some forms, each elongate sleeve comprises two openings, at least one opening in the form of a buttonhole or slit.

[0193] In some forms, wherein each rigidiser arm of the frame portion is releasably receivable within an elongate sleeve of the eye mask, the protrusion on each of the rigidiser arms is receivable with an opening formed in a wall of each elongate sleeve to retain the rigidiser arms within the respective sleeves.

[0194] In some forms, the rigidiser arms of the frame portion are configured to releasably connect with the positioning and stabilising structure of the eye mask.

[0195] In some forms, wherein the bridge portion of the eye mask defines an open space for accommodating the nose of the user or part thereof, the eye maskfurther comprising a nose cover member configured to span the open space, covering the user’ s nose or part thereof.

[0196] In some forms, wherein the nose cover member is in the form of a flexible textile or foam component.

[0197] In further forms, the inferior raised wall section comprises two raised wall sections spaced apart along the lower edge of the eye mask to define a space therebetween. In some forms, the two raised wall sections are spaced apart such that the space defined therebetween is medially located proximate or on the inferior edge of the eye mask.

[0198] In some forms, the frame body of the frame portion comprises a first connection member configured to removably connect an air conduit to the frame body.

[0199] In some forms, the frame body comprises second connection member configured to removably connect a cushion assembly to the frame body.

[0200] In some forms, the frame body is an irregularly hemispherical frame body, having a concave inner surface and a concave outer surface. In some forms, the frame body is positioned on the eye mask at or near the medial inferior edge of the eye mask such that the concave inner surface of the frame body faces the user when the eye mask is in position on the user’s face.

[0201] In certain forms, the frame body is positioned on the eye mask such that at least a portion of the frame body extends below the inferior edge of the eye mask.

[0202] In certain forms, the frame body is positioned on the eye mask such that the frame body does not extend below the inferior edge of the eye mask.

[0203] In certain forms, the frame body is shaped to define the perimeter of a circular aperture for releasably receiving an air conduit.

[0204] In some forms of the present technology, the positioning and stabilising structure is configured to overlay an otobasion superior of the user's head in use.

[0205] In some forms of the present technology, the positioning and stabilising structure is configured to overlay an otobasion superior and otobasion inferior of the user's head in use.

[0206] In some forms of the present technology, the positioning and stabilising structure comprises at least one rigidiser.

[0207] In some forms of the present technology, the positioning and stabilising structure is bifurcated to form a first bifurcated section and a second bifurcated section, wherein the first and second bifurcated sections jointly cradle a crown of the user's head in use.

[0208] In some forms of the present technology, the positioning and stabilising structure is formed from a material selected from a perforated textile, elastic fabric material, or a combination thereof.

[0209] A further aspect of the invention comprises a patient interface for use with a respiratory pressure therapy (RPT) system comprising:an eye mask as disclosed above;a frame portion comprising a frame body and two or more rigidiser arms symmetrically disposed on opposite sides of the frame body, the rigidiser arms configured to be releasably connected to the eye mask; anda cushion assembly comprising a seal forming structure, the cushion assembly configured to releasably connect to the frame portion;the frame portion and cushion assembly together forming a plenum chamber and each configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof.

[0210] A further aspect of the technology is a patient interface for use with a respiratory pressure therapy (RPT) system comprising:an eye mask comprising:an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface;a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user;a connection structure configured to connect with a frame portion; anda positioning and stabilising structure constructed and arranged to provide an elastic force to hold the eye component of the eye mask in an in-use and therapeutically effective position on the user’s head during use of RPT system;a frame portion comprising a frame body and two or more rigidiser arms symmetrically disposed on opposite sides of the frame body; anda cushion assembly comprising a seal forming structure, the cushion assembly configured to releasably connect to the frame portion;the frame portion and cushion assembly together forming a plenum chamber and each configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof.

[0211] Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is complementary to that of an intended wearer.

[0212] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0213] An aspect of certain forms of the present technology is a medical device that is easy to use, e.g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.

[0214] An aspect of one form of the present technology is a portable RPT device that may be carried by a person, e.g., around the home of the person.

[0215] An aspect of one form of the present technology is a patient interface that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment. An aspect of one form of the present technology is a humidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.

[0216] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0217] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.3 BRIEF DESCRIPTION OF THE DRAWINGS

[0218] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:Fig. 1 A shows a system including a patient wearing a patient interface, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device. Air from the RPT device is humidified in a humidifier, and passes along an air circuit to the patient. A bed partner is also shown. The patient is sleeping in a supine sleeping position.Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.Fig. 2B shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.Fig 3 A shows components of a patient interface in the form of a nasal mask in accordance with one form of the present technology.FIG. 3B shows components of a patient interface in the form of a nasal cradle in accordance with one form of the technology.FIG. 3C shows components of a patient interface in one form of the present technology.FIG. 4A shows an RPT device in accordance with one form of the present technology.FIG. 5 shows a model typical breath waveform of a person while sleeping.FIG. 6 shows a user wearing an eye mask of the present technology as a patient interface.FIG. 7 shows a posterior view of the eye mask in one form of the present technology. FIG. 8 shows an eye mask in one form of the present technology together with an unconnected air conduit and cushion apparatus.FIG. 9 shows a posterior view of the patient interface in one form of the present technology.FIG. 10 shows an anterior view of the patient interface in one form of the present technology.FIG. 11 shows a posterior view of the eye mask and cushion apparatus in a further form of the technology.FIG. 12 shows a view of the face-contacting structure of an eye mask with the functional module removed in one form of the technology.FIG. 13 A and 13B shows a show a perspective view of the construction of the eye component 7010 of the eye mask in one form of the technology.FIG.13C and FIG. 13D show a perspective view of the construction of the eye component 7010 in a further form of the technology.FIG. 13E shows a cross section of the eye component and face contacting structure comprising an air pocket in one form of the technology.FIG. 13F shows a cross section of an air pocket in the bridge portion of the facecontacting structure 7020 in one form of the technology.FIG. 14A shows a user wearing a patient interface in one form of the technology; FIG. 14B and FIG 14C shows the eye mask in one form of the technology with sleeve connection structures for connection to a respiratory therapy system; and4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0219] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0220] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.

[0221] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.4.1 THE EYE MASK AND THERAPY

[0222] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0223] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.4.2 RESPIRATORY THERAPY SYSTEMS

[0224] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.4.3 RPT DEVICE

[0225] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and isconfigured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0226] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0227] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0228] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter, an inlet muffler, a pressure generator capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers, such as pressure sensors and flow rate sensors.

[0229] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.4.4 PATIENT INTERFACE COMPONENTS

[0230] One form of non-invasive patient interface 3000, such as that shown in Fig. 3 A, comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200 together forming a cushion assembly 3150, and a positioning and stabilising structure 3300. In some forms, the patient interface may comprise a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressureat the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.

[0231] FIG. 3B shows a nasal cradle in one form of the present technology that may deliver a supply or air or breathable gas to both nares of a patient 1000, with seal-forming structure 3100 substantially external of the nose in use, leaving a nasal ridge at least partially uncovered. In one form of the present technology, shown in Fig. 3B, the seal-forming structure 3100 of the non-invasive patient interface 3000 is constructed and arranged to form a seal against the patient's airways that surrounds both nares without being partially located inside the nose. The seal-forming structure 3100 serves both nares with a single orifice, e.g. a nasal cushion or nasal cradle. In FIG. 3B the seal-forming structure 3100 according to the depicted example includes a nasal flange 3101 disposed about its periphery. This view also indicates the attachment of the plenum chamber 3200 and seal -forming structure 3100 to the frame body 3310.

[0232] FIG. 3C shows the frame portion 3307 components of the nasal cradle of FIG 3B in further detail. Frame portion 3307 comprises frame body 3310 with a pair of opposing arms 3302 extending from opposing sides of frame body 3310. Arms 3302 may be directly connected to frame body 3310, or may be indirectly connected by extension member 3355. Cushion assembly 3150 may be configured to removably connect to frame body 3310 as shown in one form in FIG 3B.

[0233] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.

[0234] The patient interfaces in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure above the ambient, for example at least 2, 4, 6, 10, or 20 cmH20 with respect to ambient.

[0235] In some forms of the present technology as seen in Figs. 6 to 11, patient interface 8000 comprises an eye mask 7000 constructed and configured to connect to a cushion apparatus 8300 and a connection port 8100. Connection portion 8100 may connect via air conduit 8200 to a respiratory therapy system during sleep. The incorporation of eye mask 7000 into the patient interface 8000 may improve the sleepquality of the user while using a respiratory therapy system, improving outcomes for the patient. The incorporation of the eye mask 7000 into the therapy system may improve the aesthetics of the patient interface 8000, potentially increasing patient compliance.

[0236] In some forms of the present technology, a plenum chamber 8320, seal forming structure 8350, together forming a cushion apparatus 8300 and / or a connection port 8100 may be connectable to the eye mask 7000 to form a patient interface configured suitable for delivery of positive pressure therapy to a patient.

[0237] The features of the patient interface are described below with numerical reference to Fig. 3 A and 3B, but may be common to any embodiment of a patient interface described herein.

[0238] In some forms of the technology, the eye mask may be used with a nasal mask or nasal cradle, for example as outlined in AU2013296145B2 and for example with the ResMed N30 or ResMed P10 nasal masks.4.4.1 Seal Forming Structure

[0239] In one form, the patient interface comprises a seal-forming structure configured to seal around an entrance to the patient’s nasal airways but not around the patient’s mouth. The seal-forming structure may be configured to seal to the patient’s lip superior. The patient interface may leave the patient’s mouth uncovered. This patient interface may deliver a supply of air or breathable gas to both nares of patient and not to the mouth. This type of patient interface may be identified as a nose-only mask.

[0240] With reference to the nasal mask of Fig. 3 A, one form of nose-only mask according to the present technology is what has traditionally been identified as a “nasal mask”, having a seal -forming structure 3100 configured to seal on the patient’s face around the nose and over the bridge of the nose. A nasal mask may be generally triangular in shape. In one form, the non-invasive patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use to an upper lip region (e.g. the lip superior), to the patient’s nose bridge or at least a portion of the nose ridge above the pronasale, and to the patient's face on each lateral side of the patient’s nose, for example proximate the patient’s nasolabial sulci. The patient interface 3000 shown inFig. 1A has this type of seal-forming structure 3100. This patient interface 3000 may deliver a supply of air or breathable gas to both nares of patient 1000 through a single orifice.4.4.2 Plenum Chamber

[0241] The plenum chamber of FIG. 3A 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal -forming structure 3100. The seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal -forming structure 3100 are formed from a single homogeneous piece of material.

[0242] The plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0243] In certain forms of the present technology as seen in FIG. 3B, plenum chamber 3200 is formed as part of the cushion assembly together with seal forming structure 3100 and is connectable to frame portion 3307.

[0244] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.

[0245] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0246] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the sealforming structure.

[0247] In some forms, the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 3200 may be made from a material having Young's modulus of 0.1 GPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and 0.3MPa. An example of such a material is silicone.4.4.3 Frame Portion

[0248] In one form of the present technology as seen in FIG. 8 and FIG. 14B, a frame portion comprises a frame body 3310, with an optional pair of rigidiser arms 3302 symmetrically disposed and extending from opposing lateral sides of frame body 3310. A number of additional structural features may form part of the frame portion, such as for example, an extension 3350 may be configured to connect the frame body 3310 and rigidiser arm 3302, with the extension 3350 located on or partly located on the rigidiser arm 3302, or on the frame 3310.

[0249] A seal forming-structure and / or plenum chamber in the form of a cushion assembly may be connectable to the frame portion.

[0250] In some forms, the frame body may be overmolded to the rigidiser arm, the mechanical interlock may comprise an enclosable section extending from the rigidiser arm that is overmolded by the material of the mask frame, and / or the enclosable section may have a portion of a bend and a hook.

[0251] The frame portion is configured for connection to a cushion assembly comprising a plenum chamber and a seal forming structure on the posterior side of the frame portion and comprises a connection port on the anterior side of the frame portion for connection to an air circuit.44 4 Connection port

[0252] Connection port 3600 allows for connection to the air circuit 4170. As shown in Fig. 3A - 3C, air conduit 4180 may be connected directly to the patient interface 3000 by the connection port 3600. The air conduit 4180 may be connected tothe frame body 3310 at the connection port 3600 by insert molding the frame onto the air conduit 4180. The connection port 3600 may be located on the patient interface 3000 and may provide either a fixed or movable connection to the air conduit 4180.

[0253] The connection port 3600 may be part of the frame body 3310 such that the frame is molded to include the connection port in one piece. Additionally, the connection port 3600 may be connected to the frame body 3310 at a limited portion or portions of its periphery. This may result in open areas between the connection port 3600 and the frame body 3310 and these open areas may include the vent(s) 3400.

[0254] In the illustrated example, the connection port 3600 is angled downward relative to the frame 3310 to cater for a majority of patients who typically have the air conduit 4180 directed downwards during treatment. This minimises looping of the air conduit 4180 and may improve seal and stability of the patient interface 3000 during treatment. It may also be possible to form the connection port 3600 separately from the frame 3310 and connect these components such that the connection port 3600 may rotate relative to the frame 3310 using a swivel connection.

[0255] It should also be understood that the flow of gas into the patient interface 3000 may be more evenly distributed in the example of the technology where no elbow is used to connect the air circuit 4170 to the patient interface 3000. The sharp bend of an elbow may cause a large density of the flow lines on one side of the elbow. This may induce jetting where the flow is condensed and this may result in a suboptimal flow into the patient interface 3000 and, specifically, the nasal pillows 3130. It should also be understood that the vent 3400, described above, may contribute to the reduction in jetting. While the use of elbows in prior masks have been to decouple tube torque by allowing at least relative rotational movement between the air circuit 4170 and the frame 3310, one form of the present technology has a particularly floppy air conduit 4180 that is capable of decoupling tube torque that conventional elbows would be responsible for.4.4.5 Ports

[0256] In one form of the present technology, a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200.In one form this allows a clinician to supply supplementary oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.4.5 RPT DEVICE

[0257] Fig. 4A shows an RPT device in accordance with one form of the present technology. The RPT device may be configured to generate a supply of breathable gas for delivery to the patient interface, for example through the air conduit. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.4.6 BREATHING WAVEFORMS

[0258] Fig. 5 shows a model typical breath waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time Ti 1.6s, peak inspiratory flow rate Qpeak 0.4 L / s, exhalation time Te 2.4s, peak expiratory flow rate Qpeak -0.5 L / s. The total duration of the breath, Tlol. is about 4s. The person typically breathes at a rate of about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.4.7 EYE MASK

[0259] The features described in relation to eye masks below may be present in or associated with eye masks exemplified in different forms throughout the description and figures, and different embodiments of the same component may be referenced with different numerals as indicated in the reference signs list in the description. Unless otherwise stated, it should be understood that the following description may apply to any eye mask embodiment, without limitation of their associated reference numerals. Embodiments referred to in the description that are referenced in their different embodiments by multiple reference numerals are listed in the reference signs section of the specification.

[0260] Eye mask of the present technology are design for use with a respiratory pressure therapy (RPT) system. When used with an RPT system, the eye mask of thepresent technology acts as a patient interface, providing structural support for an interface between the air circuit of the RPT system and the airway of the patient. The structural support is provided by the positioning and stabilising structure of the eye mask, as well as the shape and dimensions of the eye component and face-contacting structure of the eye mask, the materials used to form the face-contacting structure of the eye mask that encourage stability of positioning on the user’s face through the use of friction creating surfaces, as well as the shape and texture of the functional module which may be optionally incorporated into the eye mask.

[0261] The eye mask of the present technology is particularly useful with connection to a nasal cushion apparatus, such as the Resmed N20 or Airfit N30 nasal masks. The eye mask is configured to provide structural support for the nasal mask, ensuring the nasal cushion is held at the correct angle to provide unobstructed air flow to the patient. The eye mask is held in position over a patient’s head using a positioning and stabilising structure, while itself acting as a positioning and stabilising structing for the ROT system.

[0262] The eye mask may comprise a connection structure allowing for connection and disconnection of different nasal mask systems or components to the one eye mask via the connection structure. When disconnected from the air circuit componentry, the eye mask can be used purely as a light-blocking eye mask.

[0263] Eye masks in accordance with the present technology are exemplified in certain forms in Figs. 6 to 15 and comprise the following functional aspects: an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, a face-contacting structure connected to or contiguous with the eye component, a positioning and stabilising structure configured to provide a force to retain the eye mask on the user's face, and a connection structure configured to be directly or indirectly fluidly connectable with an air circuit of a respiratory therapy system or component thereof.

[0264] In some forms of the technology a functional module may be housed within the face-contacting structure of the eye mask. In use, the eye component blocks out light to the user's eyes, and the face-contacting structure, positioning and stabilising structure and functional module may further block out light to the eyes of the user, and aid in positioning and retaining the eye mask on the user’s face, suchthat the connection structure (such as the body of the frame portion) is presented at angle to enable efficient connection to one or more components of a respiratory therapy system and provide effective respiratory therapy to a user over a period of time, most commonly during sleep.

[0265] The eye mask in accordance with one form of the present technology is constructed and arranged to be able to provide comfort to the user in use, by blocking out light and optionally sound, and optionally provide additional comfort, light blocking or additional functionality either through the functional module, or the eye component 7010 and / or face contacting structure, or positioning and stabilising structure of the mask.

[0266] The eye mask is further structured and arranged to enable connection of the eye mask to a respiratory pressure system for delivering a therapeutic flow of air to the patient’s airways.

[0267] The eye mask may be geometrically sized to fit a head according to anthropological data. The eye mask may be dimensioned based on nationalities, races, genders, and / or ethnicities. In some forms, the eye mask may be geometrically sized to fit an Asian's head. One or more geometric parameters of the eye mask, such as width, height, and / or curvature in one or more regions of the face-contacting structure (e.g. in a nose bridge region, a region spanning the levator labii superiorus, and / or a region spanning the zygomaticus minor) may be calculated based on anthropological data from an Asian population.

[0268] The eye mask in accordance with one form of the present technology may be constructed and arranged to be able to monitor and diagnose a sleep pattern or sleep state of a user. In some forms, the eye mask may provide a corrective output to the user based on the sleep pattern or sleep state. In some forms of the present technology, the eye mask further comprises a comfort module, a sensor module, a cooling module, a flip module, a massaging module, a noise reduction component, an imaging module, or a combination thereof, which may be incorporated within or separate from the functional module. The eye mask may further comprise an electronic module for sensing and / or sensory interventions, such as an interventional light module, an interventional audio module, an interventional haptic module, a cooling / warming (thermal) module, an electro-neural stimulation (massage) module, a fluidic (air mover) module, or a combination thereof. The electronic module may be incorporated within or separate from the functional module.4.7.1 Eye Component

[0269] The eye component of the eye mask may form the anterior structure of the eye mask when the eye mask is in position over at least the orbital regions of the user’s face.

[0270] At least part of the eye component may be resiliently stretchable to enable it to be readily fitted to the user’s head, and to accommodate a variety of different head sizes. In some embodiments, the entirety of the eye mask may be stretchable and / or resiliently flexible / bendable in at least a radial direction.

[0271] In one form of the present technology, the eye mask is sized to block light to the eyes of the user. In this regard, in use, the eye component is sized such that it covers at least orbital regions of a face of a user. The orbital region includes a supraorbital region. The eye component may be configured to block light to eyes of the user. The eye component may be sized to cover more than the orbital regions of the user's face. The eye component may be sized to further cover a portion of an infraorbital region of the user in use. The eye component may be sized to further cover a portion of a nasal region of the user. The eye component may be sized to further cover a portion of a zygomatic region of the user. The eye component may be sized to further cover a forehead of the user. An oversized eye component may double up as a pillow and provide comfort to the user.

[0272] In one form of the present technology, the eye component is sized to cover at least a portion of a frontal region, orbital regions, zygomatic region and nasal bridge of a face of a user.

[0273] In one form of the present technology, the eye mask comprises at least one cavity at a user facing side. The eye component may act in combination with the facecontacting structure to form the cavity. In this regard, the cavity may be bordered by edges of the face-contacting structure and an inner surface of the eye component. The cavity may be configured to space the eye component apart from the eyes of the user, and surround the orbital regions of a patient’s face in use. Accordingly, an internal surface of the eye component is spaced apart from the eyes of the user during use.

[0274] The cavity may be characterised by a depth of about 1 cm to about 15 cm, about 1 cm to about 14 cm, about 1 cm to about 13 cm, about 1 cm to about 12 cm, about 1 cm to about 11 cm, about 1 cm to about 10 cm, about 2 cm to about 10 cm, about 3 cm to about 10 cm, about 4 cm to about 10 cm, about 5 cm to about 10 cm,about 6 cm to about 10 cm, about 7 cm to about 10 cm, or about 8 cm to about 10 cm. The depth of the cavity may be configured by varying the height of the facecontacting structure. In addition, the cavity depth may vary depending on the width of the eye mask and the cavity may vary in depth across the width and length of the cavity.

[0275] In one form of the present technology, the eye component has a curved morphology. The curved morphology may be relative to a frontal plane of the user and / or a transverse plane of the user. The curved morphology of the eye component conforms to the user's face, and provides better skin contact and light blocking.

[0276] In one form of the present technology, the eye component is resiliently flexible so as to conform to the user's head when in use.

[0277] In one form of the present technology, the eye component is configured to have a greater flexibility at the lateral edges of the eye component compared to a central region of the eye component.

[0278] In one form of the present technology, the eye component is formed as a loop or band, and the eye component is configured to loop circumferentially around a user's head.

[0279] In one form of the present technology, the eye component comprises a left section positionable over a left orbital region of the user's face and a right section positionable over a right orbital region of the user's face. The left section and right section may be similarly sized. The left and right section may be held in position relative to each other by the face-contacting structure.

[0280] In one form of the present technology, the eye component comprises at least one pocket or recess. The pocket or recess may be sized to house a sensor module, a cooling module, a flip module, a noise reduction component, an imaging module, or a combination thereof. The pocket may further house an interventional light module, an interventional audio module, an interventional haptic module, a warming module, a massaging module, an air mover module, or a combination thereof.

[0281] In one form, the external, or anterior surface of the eye component surface is substantially smooth. In other forms, the anterior surface may comprise curves, ridges or bulges that correspond to structural components formed on the posterior or user-facing side of the eye mask.

[0282] In some forms, a window may be incorporated into the eye component.

[0283] In one form of the present technology, the eye component is formed from a perforated, light blocking fabric material or composite material. In this case, direct transmission of light to the eyes is prevented by light scattering and absorption of light as it travels along the tortuous paths through the fabric material or composite material. The eye component may be made breathable, so as to provide comfort to the user. For example, silk, cotton or fleece may be used. The eye component may be formed from a material selected from perforated textile, breathable foam and / or fiber. Fabrics that are naturally thick and dense may also be used, such as velvet, heavy cotton, or woven jacquard. These fabrics have a tighter weave or a heavier weight, which helps to minimise the amount of light that can penetrate the material.Alternatively, a fabric composite material may be used. The composite material may be a laminated material. The composite material may comprise an inner fabric and an outer fabric. An intermediate layer may be sandwiched between the inner and outer fabric. The intermediate layer may be a soft flexible foam, fiber-fill, elastomeric / flexible lattice structures, pliable aggregates / beads, or combinations thereof.

[0284] In some forms of the present technology, the eye component is formed from an elastic fabric material. For example, polyester, cotton, spandex, or nylon may be used, which may be further laminated with another fabric to increase its light blocking properties.

[0285] The eye component may incorporate an optionally removable cover member for use when the eye mask is used as part of a patient interface for use with a RPT system for providing respiratory therapy. When connected to an air circuit via frame and cushion assembly, depending on the style and structure of the frame and cushion assembly, the user’s nose may remain partially uncovered when the eye mask is in position over the user’s eyes and a cushion assembly is in position against the user’s airways. In one form the cushion assembly and associated frame may be a nasal cradle that is retained primarily anteriorly and / or inferiorly to the user’s nares, such that when connected to an eye mask having a nasal curve formed along the inferior edge of the eye mask, the nasal ridge of the user remains uncovered.

[0286] This may increase the chances of light ingress to the eyes, and may also be aesthetically unwanted from a user’s perspective. The removable cover member may be configured to connect to a frame and / or cushion assembly and / or anterior surface of the eye component and shaped to cover or partially cover the user’s nose.The cover member may further be configured to cover some or all of a nasal cradle, nasal cushion, frame portion or cushion assembly.

[0287] The cover member may be formed from a flexible material such as a textile or foam.

[0288] In some forms the cover member may be formed from semi-rigid material and shaped to conform to a specific nasal and / or mask and / or cushion assembly profile.

[0289] The cover member may be integrally formed as an extension of the eye component, or may be a removable cover that can be interchanged with other cover members having different characteristics, such as colour, breathability, opaqueness, pattern, size, thickness, softness or grip-ability for example. In some forms the cover member may be sized to connect at or proximate to a bridge region of an eye mask, or may be sized to cover the entire anterior external surface of the eye mask, or part thereof.4.7.2 Face-contacting Structure

[0290] The eye mask comprises a face-contacting structure. As it is in direct contact with the user’s face, the shape and configuration of the face-contacting structure can have a direct impact on the effectiveness and comfort of the eye mask.

[0291] The design of a face-contacting structure presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces.

[0292] One type of face-contacting structure extends around the periphery of the eye mask and is intended to seal against the user’s face when force is applied to the eye mask with the face-contacting structure in confronting engagement with the user’s face. The face-contacting structure may include a pad made of a polyurethane (PU). The face-contacting structure may comprise a PU foam.

[0293] It was found that through the use of a more pliable material shaped to contour the face of the user more closely (based on anthropological data) and / or flap seal, the face-contacting structure provides a better light-tight seal compared to earlier eye masks. In earlier eye masks, the regions not engaged at all by the face-contacting structure may allow gaps to form between the face-contacting structure and the user’s face through which undesirable light pollution may ingress into the eye mask. Thelight pollution or “light leak” may decrease the efficacy and enjoyment of the overall immersive experience, or reduce the effectiveness of the eye mask as a sleep aid, for the user. In addition, previous systems may be difficult to adjust to enable application for a wide variety of head sizes. Further still, previously known eye masks and their associated stabilizing structures may often be relatively heavy and may be difficult to clean which may thus further limit the comfort and useability of the system.

[0294] Another type of face-contacting structure incorporates a flap seal of thin material positioned about a portion of the periphery thereof so as to provide a sealing action against the face of the user. Like the previous style of face-contacting structure, if the match between the face and the face-contacting structure is not good, additional force may be required to achieve a seal, or light may leak into the eye mask in-use. Furthermore, if the shape of the face-contacting structure does not match that of the user, it may crease or buckle in-use, giving rise to undesirable light penetration.

[0295] Some face-contacting structures may be limited to engaging with regions of the user’s face that protrude beyond the arc of curvature of the face engaging surface of the face-contacting structure. These regions may typically include the user’s forehead and cheek bones. This may result in user discomfort at localised stress points. Other facial regions may not be engaged at all by the face-contacting structure or may only be engaged in a negligible manner that may thus be insufficient to increase the translation distance of the clamping pressure. These regions may typically include the sides of the user’s face, or the region adjacent and surrounding the user’s nose. To the extent to which there is a mismatch between the shape of the users’ face and the face-contacting structure, it is advantageous for the face-contacting structure or a related component to be adaptable in order for an appropriate contact or other relationship to form.

[0296] In one form of the present technology, the face-contacting structure provides a target interfacing region, and may additionally provide a cushioning function. The target interfacing region is a region on the face-contacting structure where contact of the face-contacting structure with the user's face may occur. The region where contact actually occurs may change within a given sleep session, from day to day, and from user to user, depending on a range of factors including for example, where the eye mask was placed on the face, tension in the positioning and stabilising structure and the shape of a user’s face. In one form of the present technology, the face-contacting structure provides a desired shape to the eye mask toenable an effective presentation position of the frame portion of the eye mask to the components of the air conduit, to enable connection to other components in a respiratory pressure therapy system.

[0297] The face-contacting structure is connected to or contiguous with the eye component. The face-contacting structure acts together with the eye component to block out light to the user's eyes. For example, the face-contacting structure may be laminated to the eye component.

[0298] In one form of the present technology, the face-contacting structure is configured to contact at least the orbital regions of the user's face. In other forms, the face-contacting structure may also contact eyes of the user, providing slight pressure on the eyes to aid sleep.

[0299] In one form of the present technology, the face-contacting structure is configured to contact a supra-orbital region of the user's face. The face-contacting structure may be formed to contact more than the orbital regions of the user's face. The face-contacting structure may further contact an infra-orbital region of the user. The face-contacting structure may further contact a portion of a nasal region of the user. In this regard, the face-contacting structure may overlap a nose bridge region or on a nose-ridge region of the user's face. The face-contacting structure may further contact a portion of a zygomatic region of the user’s head. The face-contacting structure may further contact a forehead of the user.

[0300] In one form of the present technology, the face-contacting structure is configured to surround at least the orbital regions of the user's face. The facecontacting structure may comprise at least one orifice for housing an eye of the user. In this regard, while the eye mask obstructs light to the eyes, the eye mask does not contact the orbital regions and eyes of the user. The face-contacting structure may further not contact the eyelashes and / or eyebrows of the user.

[0301] In one form of the present technology, the face-contacting structure is configured to surround a supra-orbital region of the user's face. The face-contacting structure may be formed to surround more than the orbital regions of the user's face. The face-contacting structure may further surround an infra-orbital region of the user. The face-contacting structure may further surround a portion of a nasal region of the user. The face-contacting structure may further surround a portion of a zygomatic region of the user’s head. The face-contacting structure may further surround a forehead of the user.

[0302] In one form of the present technology, the face-contacting structure is sized to contact at least a portion of a frontal region, orbital regions, zygomatic region and nasal bridge of a face of a user.

[0303] In one form of the present technology, the face-contacting structure is characterised by a height of about 1 cm to about 15 cm, about 1 cm to about 14 cm, about 1 cm to about 13 cm, about 1 cm to about 12 cm, about 1 cm to about 11 cm, about 1 cm to about 10 cm, about 2 cm to about 10 cm, about 3 cm to about 10 cm, about 4 cm to about 10 cm, about 5 cm to about 10 cm, about 6 cm to about 10 cm, about 7 cm to about 10 cm, or about 8 cm to about 10 cm. The height of the facecontacting structure creates a cavity such that the eyes of the user are spaced apart from the eye component.

[0304] In one form of the present technology, the face-contacting structure comprises a bridge portion or a saddle-shaped region for saddling the nasal region of the user's face. The bridge portion saddles between the left and right orbital sections of the eye component. The bridge portion may be constructed to form a seal in use on a nose bridge region or on a nose-ridge region of the user's face. The bridge portion may be made of a different material (for example, a stiffer material) than the rest of the face-contacting structure to provide stability to the eye mask when used. For example, the bridge portion may be a thermoformed material.

[0305] In one form of the present technology, the bridge portion is formed as a single structure. In this regard, the bridge portion may be formed by curving the material such that it forms a parabola. In one form of the present technology, the bridge portion is characterised by a height to width ratio of about 1 : 1 to about 5:1, about 1:1 to about 4:1, about 1:1 to about 3:l, about 1:1 to about2:l, or about 1.5:1 to about 2:1.

[0306] In one form of the present technology, the face-contacting structure is shaped at the bridge portion to accommodate, connect to and at least partially surround a connection structure configured to directly or indirectly connect to one or more components of the respiratory pressure therapy system. The bridge portion region of the face-contacting structure in some forms comprises areas of greater size, width, depth, height or thickness at or proximate to the frame portion. This increased size in one or more directions may improve the light-blocking ability of the mask at or near the bridge portion and / or frame, which may be required following connection of a cushion assembly to the frame portion. Cushion assemblies of different sizes mayresult in the face-contacting structure being held closer or further from the user’s face in some examples, and adapting the size and shape of the face contacting structure in this region may help prevent this.

[0307] In one form of the technology, the face contacting structure may comprise one or more air pockets, or regions of compression and / or deformation. Such regions allow for additional compressibility of the face-contacting structure against the user’s face, which may improve stability, angle of presentation of the frame portion, or lightblocking effectiveness. Air pocket regions in the face-contacting structure may be increased or decreased in size, either during manufacture, or by the user, to accommodate cushion assemblies of different sizes being connected to the frame portion of the eye mask and main a stable, light-blocking fit of the eye mask.

[0308] In one form of the present technology, the face-contacting structure is contoured to conform to the user's face. In one form of the present technology, the face-contacting structure is contoured to conform to the user's face when in use. For example, the face-contacting structure may be resiliently flexible.

[0309] In one form of the present technology, the face-contacting structure is substantially similarly sized to, or smaller than the eye component. In this regard, the face-contacting structure is not visible when the eye mask is worn. For example, when the eye component and the face-contacting structure together form a loop or a band, the face-contacting structure may not be visible when the eye mask is worn.

[0310] In one form of the present technology, the face-contacting structure is larger than the eye component. The face-contacting structure may form a border surrounding the eye component. Further, portions of the face-contacting structure may be visible when the eye mask is worn. For example, when the eye component comprises left and right orbital sections, a bridge portion of the face-contacting structure may be exposed and visible when the eye mask is worn.

[0311] In certain forms of the present technology, the face-contacting structure is constructed from a biocompatible material, e.g. silicone rubber. The face-contacting structure may be constructed from a soft, flexible, resilient material such as silicone. The face-contacting structure may be constructed from a breathable foam. The foam may have a thickness of about 1 cm to about 10 cm. The face-contacting structure may have a gradient of decreasing thickness towards an orifice configured to house an eye of the user in order to improve the breathability of the eye mask. The face-contacting structure may further be perforated to increase the breathability of the eye mask.

[0312] In other forms of the present technology, the face-contacting structure is constructed from a perforated, light blocking fabric material or composite material. The face-contacting structure may be made breathable, so as to provide comfort to the user. The face-contacting structure may be formed from a material selected from perforated textile, breathable foam and / or fiber. Fabrics that are naturally thick and dense may also be used, such as velvet, heavy cotton, or woven jacquard. These fabrics have a tighter weave or a heavier weight, which helps to minimise the amount of light that can penetrate the material. Alternatively, a fabric composite material may be used. The composite material may be a laminated material.

[0313] In some forms of the present technology, the face-contacting structure is formed from an elastic fabric material. For example, polyester, cotton, spandex, or nylon may be used, which may be further laminated with another fabric to increase its light blocking property.

[0314] In one form of the present technology, the face-contacting structure is constructed from a composite material. The composite material may comprise an external fabric (or fabric composite) layer surrounding an inner foam. The fabric layer may be thermoformed with the foam. For example, the fabric may be laminated to one or all sides of the foam and placed in a 2-piece mold. Heat and pressure are then applied, which permanently molds the laminate into a semi-rigid product. The foam may be a memory foam, high density foam, low density foam, or a combination thereof. The foam may be selected from silicone, polyester, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomer, polycarbonate-acrylonitrile butadiene sytene (PC-ABS), polyethylene terephthalate (PET), latex, or a combination thereof. For example, memory foam may be used, which comprises polyurethane with chemicals that increase its viscosity and density. It is often referred to as "viscoelastic" polyurethane foam, or low-resilience polyurethane foam (LRPu).

[0315] The foam may have a cell structure that reacts to body heat and weight, helping relieve pressure points, preventing pressure sores, and the like. The density and layer thickness of the foam may provide a different feel to the user. A high-density foam may have better compression ratings over the life of the eye mask. A lower-density one will generally have slightly shorter life due to the compression thattakes place after repeated use. Cell structures can vary from very open to almost closed cell. The open cell foam structure includes a plurality of interconnected cells, wherein the windows between the adjacent cells are broken and / or removed. In contrast, a closed cell foam has substantially no interconnected cells and the windows between the adjacent cells are substantially intact. The tighter the cell structure, the less airflow through the foam. Breathable foam will have a more open cell structure, allowing higher airflow, better recovery, and lower odour retention.

[0316] In one form of the present technology, the foam comprises an open cellular structure. The cellular structure may be about 10 cells to about 40 cells per inch, about 15 cells to about 40 cells per inch, about 20 cells to about 40 cells per inch, about 25 cells to about 40 cells per inch, or about 30 cells to about 40 cells per inch.

[0317] In one form of the present technology, the foam is characterised by a hardness of about 35 pounds-force to about 100 pounds-force, about 35 pounds-force to about 90 pounds-force, about 35 pounds-force to about 80 pounds-force, about 35 pounds-force to about 70 pounds-force, about 35 pounds-force to about 60 pounds-force, or about 35 pounds-force to about 50 pounds-force.

[0318] In one form of the present technology, the foam is characterised by a density of about 1.2 pounds per cubic foot to about 2.0 pounds per cubic foot, about 1.2 pounds per cubic foot to about 1.8 pounds per cubic foot, or about 1.2 pounds per cubic foot to about 1.6 pounds per cubic foot.

[0319] In one form of the present technology, the composite material comprises at least one air pocket. The air pocket may be between the external fabric and the inner foam. This may be formed by, for example, laminating a side of the foam to the fabric and providing an excess of fabric to obtain a loose fit around the foam when thermoforming. It was found that the air pocket provides flexibility during use, in that the eye mask is able to further conform to an individual's facial contours without excessive pressure. The air pocket also increases the surface area of contact of the external fabric with the user's face, thus providing better light blocking and stability during use.

[0320] In one form of the present technology, the composite material is characterised by a cross-sectional area, wherein the air pocket is about 1% to about 30%. In other forms of the present technology, the cross-sectional area of the air pocket relative to the composite material is about 5% to about 30%, about 10% toabout 30%, about 12% to about 30%, about 14% to about 30%, or about 15% to about 30%.

[0321] In one form of the present technology, the face-contacting structure comprises an area or region of a user-facing surface of the face-contacting structure comprising a material that promotes friction and / or has a high co-efficient of friction. In some forms, the material is silicon, polished silicon, synthetic polymer or rubber. The application or inclusion of a material to promote friction may aid in stabilising the eye mask on the user’s face during sleep, and / or may aid in holding or supporting the eye mask at an angle to effectively present the frame portion 7800 for connection to an RPT system.

[0322] In some forms, the material that promotes friction may be incorporated at or over one or more regions or areas that contact the user’s forehead, cheeks, nasal or zygomatic regions of the face. In some forms, the material is silicon, polished silicon, synthetic polymer or rubber. In some forms, material comprises an adhesive suitable for connection to skin such as a hydrogel, double coated tape, hydrocolloid or a pressure-sensitive adhesive.4.7.3 Pocket or Recess for Housing Functional Module

[0323] In some forms, the eye mask may comprise one or more pockets or recesses. The pocket or recess may be sized to house a functional module. The pocket or recess may substantially traverse at least between the left and right supraorbital foramen of a user's head in use. The functional module may comprise components such as a sensor component, sensory intervention component, a cooling component, a flip component, a noise reduction component, an imaging component, a massage component, a comfort component or a combination thereof.

[0324] In some forms, the pocket or recess may house electronics, such as a sensor component, sensory intervention component (such as using light, haptic, audio), a cooling / warming (thermal) component, a noise reduction component, electro-neural stimulation (massaging) component, or a combination thereof.Preferably, the pocket or recess may house electronics, such as an EEG sensor, a PPG sensor, a cooling unit and a battery.

[0325] The pocket or recess may be associated with the eye component, or the positioning and stabilising structure. The pocket or recess may be positioned on any portion of the eye mask as long as the components are suitably enabled to perform their function. For example, the pocket or recess may be positioned adjacent to the user's ears for housing a noise reduction component, or positioned adjacent to a forehead region of the user for housing a cooling component.

[0326] In some forms, the pocket comprises at least one window for exposing a portion of the electronic module. The portion may be an electrode of an electronic module. The electrode may be for contacting the user's skin in order to pick up a bioelectric signal from the user. The portion may be an outlet of a cooling module, for providing cooling means to the covered eyes of the user. Accordingly, the window may be appropriately sized.

[0327] In some forms, the pocket comprises at least one electrode on a user facing side of the eye mask. The electrode may traverse a cross section of the pocket, in order to provide electrical contact between an electronic module and the user's skin.

[0328] In one form of the present technology, the face-contacting structure comprises a recess formed within the surface of the face-contacting structure. The recess may be positioned at a forehead or frontal region of the user when in use. The recess may be sized to extend substantially between orbital regions of the user. The recess may be dimensioned to substantially traverse at least between the left and right supraorbital foramen of a user's head in use. The recess may be elongated. The recess may be configured to house a functional module. In some forms, the functional module may be an electronic module for sensing and / or sensory interventions, a cooling module, a massage module, a comfort module or a combination thereof. The face-contacting structure comprising the recess allows for the modularization of the eye mask, in that the user may choose the desired functionality based on their needs. This also allows the functional module to be removed so as to clean the eye mask.

[0329] In one form of the present technology, the recess comprises a connector for engaging with a complementary connector on the functional module. For example, the connector and complementary connector may be a hook-and-loop fastener such as Velcro, a snap fit joint, snap fastener such as press stud button, magnetic catch, and / or groove and complementary protrusion.

[0330] In some forms, the connector is in the form of a magnetic connector incorporated within the base and / or sides of the recess. The magnetic connector may be one or more discrete magnetic clasps, buttons or magnetic shapes, with either the positive or negatively charged component of the magnetic connector embedded within or connected to the recess or a recess surround, and the complementary positively or negatively charged component embedded or connected to the functional module. The number of magnetic connectors required may alter depending on the weight of the functional module and the strength of individual magnets. In some forms the magnetic connectors may be spaced along the width of the recess and correspondingly, across the width of the function module.

[0331] In other forms, the magnetic connection may be formed as a scaffold or cage incorporated with the recess and face-contacting structure and / or eye component, the scaffold or cage providing both magnetic connection to the functional module, and structural support to the eye mask or components thereof.

[0332] In some forms the magnetic scaffold or cage extends along at least a portion of the length of the base of the recess and at least partially within or on one or more of the perimeter walls of the recess.

[0333] In some forms, the pocket is formed from substantially the same material as the eye component and / or the positioning and stabilising structure of the eye mask. A slit may be provided in a portion of the eye component and / or the positioning and stabilising structure of the eye mask to form the pocket. In some forms, the pocket further comprises a material in order to reinforce the pocket. For example, the material may be a polymer sheet or foam. The polymer may flexible but tough. The material may be a thicker fabric.

[0334] In some forms, the pocket or recess comprises engagement means for releasably engaging with the functional module. The engagement means may be a friction fit with an external surface of the functional module, or may be a snap fit, such as an annular snap fit or cantilever snap fit, with a corresponding member on the functional module. In some embodiments, a non-mechanical coupling, such as magnetic coupling, may be used to retain the functional module in the pocket or recess.

[0335] In some forms, the recess may be characterised by a depth or distance from a base portion of the recess to a user-facing surface of the surrounding facecontacting structure, or user-facing surface of a perimeter wall of about 0.5 cm to about 5 cm, about 0.5 cm to about 4 cm, about 0.5 cm to about 3 cm, about 0.5 cm to about 2 cm, about 0.75cm to about 2 cm, about 1 cm to about 2cm. The depth of the recess varies across the width or length of the recess to accommodate different shaped functional modules and / or to facilitate connection between components.

[0336] In some forms, the depth of the recess is greater near the centre of the recess compared to the depth at the lateral edges of the recess.

[0337] In some regions of the recess, the depth will be about 1mm to about 20mm, about 2mm to about 20mm, about 3mm to about 20mm, about 4mm to about 20mm, about 5mm to about 20mm, about 6mm to about 20mm, about 7mm to about 20mm, about 8mm to about 20mm or about 9mm to about 20mm.

[0338] In some forms, increasing the depth of the recess results in reducing the thickness of the eye component and / or face-contacting structure that the recess is formed within, and increased thickness of the eye component and / or face-contacting when the recess is shallow. In some forms the combined thickness of the eye component and face-contacting structure between the base of the recess (or posterior surface of the face-contacting structure) and the anterior surface of the eye component is in the range of 3mm - 50mm. In some forms, the thickness extends from 3mm -10mm near the centre of the recess to 10mm - 30mm closer to the lateral sides of the eye mask.

[0339] Effectively thermoforming the thinner regions of the eye mask (for example where the combined thickness of the eye component and face-contacting structure is less than 10mm) provides a particular challenge to ensure the mask has the required strength, while retaining flexibility. By using three layers of material in the thermoforming process as discussed further below, and optionally by the inclusion of a structural webbing or magnetic or non-magnetic cage or scaffold as discussed above, this challenge may be overcome.

[0340] The ability to alter the recess depth without compromising the structural integrity of the eye mask allows for the functional module to be adapted to a range of different shapes that may be required to incorporate various electronic or sensorcomponents, and the eye mask to be correspondingly shaped to effectively receive the module.4.7.4 Functional Module

[0341] The components as described above may be housed individually in the eye mask, or alternatively may be housed as a single entity in a functional module.

[0342] In some forms of the present technology, a functional module is provided. The functional module may substantially traverse at least between the left and right supraorbital foramen of a user's head in use. As mentioned above, functional components such as a sensor component, a cooling component, an imaging component, a pivot component, a massage component, or a combination thereof may be housed within the functional module. In particular, the functional module may house a sensor component, a noise reduction component, a pivot component, a cooling component, an imaging component, a massage component, a visual component, an audio component, a charging component, a power supply, or a combination thereof. For example, the sensor component may be selected from one or more of the following: a electroencephalography (EEG) sensor, a photoplethysmography (PPG) sensor, electromyography (EMG) sensor, electrooculography (EOG) sensor, a pulse oximeter (SpO2) sensor, respiratory rate (RR) sensor, heart rate (HR) sensor, and a heart rate variability (HRV) sensor.

[0343] The functional module may be removably attached to or housed within the pocket or recess of the eye mask. This provides convenience to the user, as the eye mask may be washed without damaging the electrical components. The functional module may be removed to recharge the battery component. As the components are housed within a casing formed by the functional module, less interference with ambient environment may provide a better sensing and / or readout. The functional module, when provided as a single entity and / or made difficult to dismantle, also discourages the user from dismantling it, thus prolonging its usable life.

[0344] In some forms, the functional module is configured to contour a forehead region of the user in use. The functional module may thus be formed such that it is elongate and may be curved such that it is adjacent to and / or in contact with a forehead region of the user in use. In other forms, the functional module has a crescent shape or a banana shape. In other forms, the functional module has a taperedshape towards its ends. In other forms, the functional module is arcuated. In some forms, the functional module is sized to substantially traverse the frontal bone of the user in use. In some forms, the functional module is sized to substantially traverse at least between the left and right supraorbital foramen of the user in use. In some forms, the functional module is flexible so as to conform to the user's head in use.

[0345] In other forms, the functional module comprises a first end portion, a second end portion and a middle portion. The middle portion is sandwiched between the first end portion and the second end portion. The functional module may comprise a convex side and a concave side. The end portions may have a first width. The middle portion may have a second width. The width is the perpendicular distance (relative to a length of the functional module), traversing the convex or concave side from a top surface to a bottom surface of the functional module when in use (and relative to gravity). The width may be parallel to a sagittal plane of the user. In some forms, the end portions and middle portion may have a substantially similar width. Alternatively, the width of the middle portion may be wider than the end portions, or the width of the end portions may be wider than the middle portion.

[0346] In some forms, the functional module comprises end portions with a rounded edge. It was found that this helps to distribute the pressure felt by the user when in use.

[0347] In some forms, the functional module comprises a convex (external facing) or first side and a concave (or user facing) or second side. The convex surface may comprise a backing formed from flexible material. The backing may be curved, crescent shaped, or arcuated. The material may be characterised by a hardness.Hardness refers to how much weight a material can support without deforming or breaking. The material may be characterised by a flexibility. Flexibility refers to how a material may be bent out of shape or compressed without breaking, and returned to its original shape. The hard backing acts to protect the components within the functional module. The material may be flexible so as to conform to an anthropological head shape of the user.

[0348] In some forms, the functional module comprises ridges, ribs, curves, channels or bulges on the convex side of the module.

[0349] In some forms, the material is characterised by a hardness. The hardness may be characterised by a Vickers, Brinell, Rockwell, Mohs, Knoop and / or Shore scale. For instance, the material may have a Shore hardness of about 60 to about 90. In other forms, the Shore hardness is about 65 to about 90, about 70 to about 90, about 75 to about 90, about 80 to about 90, or about 85 to about 90. For example, a material interfacing with user may have a Shore A hardness of about 5 to about 80; or preferably about 20 to about 40.

[0350] In some forms, the material is characterised by a Young's modulus. For instance, the material may have a Young's modulus of about 0.0001 GPa to about 5 GPa. In other forms, the Young's modulus is about 0.0001 GPa to about 4.5 GPa, about 0.0001 GPa to about 4 GPa, about 0.0001 GPa to about 3.5 GPa, about 0.0001 GPa to about 3 GPa, about 0.0001 GPa to about 2.5 GPa, about 0.0001 GPa to about 2 GPa, about 0.001 GPa to about 2 GPa, about 0.01 GPa to about 2 GPa, or about 0.1 GPa to about 2 GPa. For example, the textile or fabric used for the eye mask may have a Young's modulus of about 0.5 GPa to about 5GPa. Silicone may have a Young's modulus of about 0.0005 GPa to about 0.1 GPa.

[0351] In some forms, the material is characterised by flexural strength of about 30 MPa to about 300 MPa. In other forms the flexural strength is about 30 MPa to about 300 MPa, about 50 MPa to about 300 MPa, about 70 MPa to about 300 MPa, about 100 MPa to about 300 MPa, about 120 MPa to about 300 MPa, about 140 MPa to about 300 MPa, about 160 MPa to about 300 MPa, about 180 MPa to about 300 MPa, or about 200 MPa to about 300 MPa.

[0352] In some forms, the convex side further comprises a fabric. The fabric may be adjacent to the backing. The fabric may be adjacent to an external facing side of the backing. The fabric provides a soft touch feel and comfort to the user. For example, elastomeric nonwoven fabric, knitted fabric, woven fabric, spacer fabric, or a combination thereof may be used. Such materials have been described above.

[0353] In some forms, the concave side comprises a user-contacting layer. The user-contacting layer may be formed from a fabric, a fabric composite, or silicone cushion. These materials may provide a soft touch feel and comfort to the user in use. For example, elastomeric nonwoven fabric, knitted fabric, woven fabric, spacer fabric, or a combination thereof may be used.

[0354] In some forms, the fabric at the convex side and the user-contacting layer are contiguous or formed from a single material.

[0355] In some forms, the concave side comprises at least one electrode. In some forms, the user-contacting layer comprises at least one conductive material for use as an electrode. The electrode may be adhered to an external facing side of the usercontacting layer such that it may be in contact with the user's head when in use.Alternatively, the electrode may be printed on the user-contacting layer.

[0356] The conductive material may be conductive silicone or soft polymer. Such material may be compounded with conductive material such as carbon. Conductive silicone may be in molded with the silicone cushion, and forms an external surface of the concave side. In this regard, the conductive silicone is exposed such that it may contact the user's head in use. In use, the conductive silicone contacts with the user's head such that biological signals may be received and transmitted to the components, and / or output from the components may be transmitted to the user. Accordingly, the conductive silicone or soft polymer acts as a dry electrode when electrically connected to a component.

[0357] In some forms, the conductive material is formed as a strip. The strip may be positioned perpendicularly to a length of the concave side. In some forms, the conductive material is characterised by a length which is substantially similar to the width of the concave side. The conductive material may be positioned at regular intervals along the length of the concave side of the functional module. A component, for example a sensor, may be positioned between and electrically connected to the two conductive materials. This helps in ensuring reliability in the receiving and transmitting of data and / or signal.

[0358] In some forms, the conductive material is characterised by a width. In some forms, the width of the conductive material at a middle portion of the functional module is relatively smaller than the width of the conductive material at an end portion. It was found that having a relative larger width for the conductive material at the ends allows for better contact with the user's head, and hence better receipt and transmission of signals. It was found that it provides a more reliable signal acquisition from the targeted regions on the head given the anthropological variations.

[0359] In some forms, the width of the conductive material when adjacent to an end portion relative to the width of the conductive material when adjacent to a middle portion is about 4: 1 to about 1.1 : 1. In other forms, the ratio is about 3 : 1 to about 1.1:1, about 2:1 to about 1.1:1, about 1.9:1 to about 1.1:1, about 1.8:1 to about 1.1:1, about 1.7:1 to about 1.1:1, about 1.6:1 to about 1.1:1, about 1.5:1 to about 1.1:1, about 1.4:1 to about 1.1:1, or about 1.3:1 to about 1.1:1.

[0360] In some forms, the conductive material comprises an electrical contact, the electrical contact extending inwardly towards a cavity of the functional module. The electrical contact may penetrate the user-contacting layer in order to make contact with a component housed within the functional module. In other forms, the electrical contact extends over the top and / or bottom side of the functional module and towards the convex side. In this way, the electrical contact skirts around the user-contacting layer in order to make contact with a component housed within the functional module. When multiple electrical contacts are present, they may be aligned parallel to each other so as to facilitate connection with the components. As the electrical contact is electrically connected to the conductive material, by connecting the electrical contact to the component, the component is electrically connected to the conductive material, and may thus receive and / or transmit signals from / to the user. For example, the electrical contact may be inserted into a mating port in a component for electrical connection.

[0361] In some forms, the functional module comprises a foam. The foam may be adjacent to the user-contacting layer at the concave side and housed within a cavity of the functional module. The foam may be adjacent to an internal facing side of the user-contacting layer. The foam provides additional support and comfort to the user when in use.

[0362] In some forms, the functional module comprises a cavity for housing the components. The cavity may comprise at least one component-retaining structure for engaging a component. The component may be detachable from the componentretaining structure, such that a particular component may be switched out for another component with different functionality, or to replace a component that has ceased to function or is at the end of its lifecycle. For example, the component (and / or the circuitry to which it is electrically coupled, if applicable) may be releasably attached to the component-retaining structure. To this end, an external surface of a componentmay form a friction fit with an internal surface of a wall of a component-retaining structure, or may form a snap fit, such as an annular snap fit or cantilever snap fit, with the wall or other internal or external part of the component-retaining structure, or may form a spring release fit. In some embodiments, a non -mechanical coupling, such as magnetic coupling, may be used to retain the component in a respective retaining structure.

[0363] In some forms, the component is fixedly attached to the componentretaining structure. For example, the component may be attached within the component-retaining structure via co-molding, adhesive, or a combination thereof.

[0364] In some forms, the functional module comprises a support in its cavity thereof. The support provides reinforcement and protection to the components.

[0365] In some forms, the functional module comprises a silicone or soft polymer material within its cavity. The soft material absorbs a shock from an impact (for example when dropped), thereby providing some protection to the components.

[0366] In some forms, the user-contacting layer comprises a window for exposing a portion of the component. The portion may be an electrode of a sensor component. The electrode may be for contacting the user's skin in order to pick up a bioelectric signal from the user. The portion may be an outlet of a cooling component, for providing cooling means to the covered eyes of the user. Accordingly, the window may be appropriately sized.

[0367] In some forms, the functional module comprises a connector for connecting with a complementary connector in a recess of the eye mask. The connector and complementary connector thus mate with each other. The connector and complementary connector may be a friction fit, hook-and-loop fastener, a snap fit joint, snap fastener, magnetic catch, groove and complementary protrusion, spring release engagement, or a combination thereof. The connector may be positioned at a middle portion or at either or both end portions of the functional module. The connector ensures that the functional module is retained in position during use.

[0368] In some forms, the functional module comprises a magnetic charging port. The magnetic charging port may be configured to engage with a magnetic cover.

[0369] In some forms, the functional module comprises one or more ports such as communication or power connection ports, such as but not limited to USB ports andcharging ports. In some forms the ports may be located on the concave face or one or more side faces of the functional module to allow ease of connection when the eye mask and functional module is not in use on the user’s face. The positioning of a charging port may be deliberately selected to ensure the eye mask cannot be worn while the functional module battery is being charged, or is otherwise connected to an external communication or power source. This reduces the risk of overheating of the product that may occur if the user wears the product on charge while sleeping.

[0370] In some forms, the functional module is characterised by a weight about 40 g to about 200g. In other forms, the weight is about 40 g to about 180g, about 40 g to about 160g, about 40 g to about 150g, about 40 g to about 140g, about 40 g to about 130g, about 40 g to about 120g, about 40 g to about 110g, about 40 g to about 100g, about 40 g to about 90g, or about 40 g to about 80g.

[0371] In one form of the present technology, the eye mask further comprises a functional module in the form of an insert. The insert is sized to fit into the recess and has the function of improving comfort, stability or light blocking ability of the eye mask. The insert may be formed from a material similar to the face-contacting structure. Accordingly, the insert may also comprise a complementary connector for mating with the connector in / on or adjacent to the recess.

[0372] In contrast to the other functional modules disclosed herein, the insert may not contain any additional functional components within its body. In other words, the insert may be a "blank" component, which may be used to fill the recess. The insert may also be sized to fit into the pocket of the eye covering component.

[0373] In some forms the functional module is a stabilizing module and may comprise foam or other compressive material. The functional module may be sized to provide additional support to the user’s forehead region, or shaped to ensure the eye mask in held in an effective position on the user’s face in order to effective block light from the user’s eyes, or to effectively position the frame portion 7800 of the eye mask such that an effective connection to one or more components of an RPT system is enabled. In some forms, the stabilizing module has a width on the user-facing surface along the superior-anterior surface on 10mm - 70mm.

[0374] In some forms, the functional module comprises an area or region of a user-facing surface of the functional module comprising a material that promotesfriction and / or has a high co-efficient of friction. In some forms, the material is silicone, polished silicone, synthetic polymer or rubber. The application or inclusion of a material to promote friction may aid in stabilising the eye mask on the user’s face during sleep, and / or may aid in holding or supporting the eye mask at an angle to effectively present the frame portion 7800 for connection to an RPT system.

[0375] In some forms, the material is silicone, polished silicone, synthetic polymer or rubber. In some forms, material comprises an adhesive suitable for connection to skin such as a hydrogel, double coated tape, hydrocolloid or a pressuresensitive adhesive.

[0376] In one form of the present technology, the material that promotes friction is a gripping or grippy material. The gripping material increases friction between the material and the user's face so as to improve the stability of the eye mask when worn. The friction makes the eye mask more resistant to movement relative to the user’s head. This is in contrast to tacky materials, which are those that have a slightly sticky feel to them, but they do not leave any residue when removed. One way to impart stickiness to the surface is to polish regions of the surface to provide the required grip while avoiding excessive tackiness.

[0377] The gripping material may cover at least a portion of the user-facing surface, or may cover the whole user-facing surface. Having the gripping material cover only portions of the user-facing surface reduces a “sticky” feeling by the user which might cause some discomfort. In particular, the gripping material may be formed as at least one patch or at least one strip traversing across the user-facing surface. Alternatively, an array of various shapes such as circles, dots, lines, wavy lines, triangles, chevrons may be used. Alternatively, a pattern such as concentric circles or squares may be used.

[0378] Examples of gripping material include, but are not limited to, silicone, PVC foam and / or vulcanised rubber. A fabric made with nanofibres so as to increase its frictional force when in contact with another surface may also be used as a gripping material. The fabric with gripping material or gripping material may be textured with dots, lines and / or other patterns. For example, the gripping material may be micro-patterned with an array of dots or squares.

[0379] The gripping material may be characterized by a static friction or sliding friction. The gripping material may be characterized by a friction coefficient of about 0.1 p to about 0.9 p.4.7.5 Connection Structure

[0380] The eye mask comprises a connection structure that may be configured to removably receive a frame portion or component of an RPT system to connect to an air circuit of the RPT system. This configuration enables the eye mask to be used both without a frame portion and associated RPT system connected, for light-blocking only, or with a frame portion providing a connection to the air circuit of an RPT device, enabling the eye mask to be used for both light-blocking and respiratory pressure therapy. The connection structure may also be configured such that the eye mask may connect to multiple different components or different versions or types of mask for use with an RPT system.

[0381] In some forms, the connection structure is in the form of one at least one sleeve integrated within or connected to the eye mask, and in some forms positioned along or partially along the inferior edge of the eye mask. The sleeves may be formed within the face contacting structure and / or eye component and may be configured to be part of the of walls that surround the cavity of the eye mask, particularly the walls the extend along the inferior edge of the cavity, such as the inferior raised wall section. In this form, the walls are configured with at least one sleeve cavity that can receive a component of the frame portion, such as one or more rigidiser arms, to permanently or removably secure the frame in a central position along the inferior edge of the eye mask. The one or more sleeves may extend around a bridge portion of the eye mask, or may be formed as two or more separate sleeves.

[0382] In some forms the at least one rigidiser arm may be crescent shaped.

[0383] In some forms the at least one elongate sleeve and the at least one rigidiser arm may be arranged to allow the at least one rigidiser arm to move substantially axially inside the at least one elongate sleeve.

[0384] In some forms an end portion of the at least one rigidiser arm may be affixed to the at least one elongate sleeve.

[0385] In some forms the at least one rigidiser arm may be affixed to the at least one elongate sleeve by clamping, buttoning, snapping a cover over the end, and / or snapping on an external part.

[0386] In some forms if the at least one rigi diser arm is affixed to the at least one sleeve by snapping on an external part, snapping on an external part is be achieved by aligning the at least one elongate sleeve and the at least one rigidiser arm, pushing the at least one rigidiser arm inside the sleeve, and fixing both sleeve and rigidiser arm to the external part.

[0387] In some forms the at least one rigidiser arm is incapable of stretching and is relatively more rigid than the at least one elongate sleeve.

[0388] In some forms the connection structure may comprise at least one retaining means, said retaining means comprising a loop, a sleeve and / or a pocket, for receiving the at least one rigidiser arm and holding the at least one rigidiser arm in place.

[0389] In some forms the at least one retaining means may be formed on or in the at least elongate sleeve, the at least one rigidiser arm may be affixed to a guiding element provided to the at least one elongate sleeve, the at least one rigidiser arm may be affixed to the at least one elongate sleeve at one localized point or area only, the guiding element may be a loop- or sheath-like portion or passage or a pocket into which or through which the at least one rigidiser arm extends, the guiding element may allow longitudinal expansion or retraction of the at least one elongate sleeve relative to the at least one rigidiser arm and / or may allow substantially free movement or floating of the at least one rigidiser arm relative to the at least one elongate sleeve.

[0390] Further forms of the connection structure are discussed in with reference to specific embodiments of the technology below.4.7.6 Positioning and Stabilising Structure

[0391] The patient interface and eye mask of the present technology may be held in sealing position against the user’s face by the positioning and stabilising structure. The positioning and stabilising structure may comprise and function as “headgear”since it engages the patient’s head in order to hold the patient interface in a sealing position.

[0392] The eye mask may comprise a positioning and stabilizing structure for retaining the eye mask on the user’s head. The positioning and stabilising structure may be removable from the eye mask. The positioning and stabilizing structure may be responsible for providing forces to counter gravitational forces of the eye component and / or face-contacting structure. In the past such structures have comprised rigid structures that are typically applied to the head under tension to maintain the eye mask in its operational position. Such systems have been prone to exert a clamping pressure on the user’s face which can result in user discomfort at localised stress points. Also, previous eye masks may be difficult to adjust to allow wide application to different head sizes. Further, known eye masks may be heavy and difficult to clean, which further limits the comfort and useability.

[0393] The face-contacting structure of the eye mask of the present technology may be held in a contact position in use by the positioning and stabilising structure.

[0394] In one form the positioning and stabilising structure provides a retention force at least sufficient to hold the eye mask in contact with the user's face.

[0395] In one form the positioning and stabilising structure provides a retention force to overcome the effect of the gravitational force on the eye mask.

[0396] In one form the positioning and stabilising structure provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the eye mask, such as from accidental interference with the eye mask.

[0397] In one form of the present technology, a positioning and stabilising structure is provided that is configured in a manner consistent with being worn by a user while sleeping. In one example the positioning and stabilising structure has a low profile, or low cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure comprises at least one flat strap.

[0398] In one form of the present technology, the positioning and stabilising structure is configured so as not to be too large and bulky to prevent the user from lying in a supine sleeping position with a back region of the user’s head on a pillow.

[0399] In one form of the present technology, the positioning and stabilising structure is configured so as not to be too large and bulky to prevent the user from lying in a side sleeping position with a side region of the user’s head on a pillow.

[0400] In one form of the present technology, the positioning and stabilising structure has a width substantially similar to the eye component. In other forms of the present technology, the positioning and stabilising structure has a width smaller than a width of the eye component.

[0401] For example, the positioning and stabilising structure may have a width of about 10 mm to about 100 mm, about 10 mm to about 90 mm, about 10 mm to about 80 mm, about 10 mm to about 70 mm, about 10 mm to about 60 mm, about 10 mm to about 50 mm, or about 10 mm to about 40 mm. The positioning and stabilising structure may have a thickness of about 1 mm to about 100 mm.

[0402] For example, the positioning and stabilising structure may have a length of about 100 mm to about 800 mm, about 100 mm to about 750 mm, about 100 mm to about 700 mm, about 100 mm to about 650 mm, about 100 mm to about 600 mm, about 100 mm to about 550 mm, about 100 mm to about 500 mm, about 100 mm to about 450 mm, or about 100 mm to about 400 mm.

[0403] The positioning and stabilising structure is attached to the eye component, and provides a resilient force such that the face-contacting structure is pressured against the user's face. For example, the positioning and stabilising structure may be attached to opposed ends of the eye component. Alternatively, the positioning and stabilising structure may form a loop or band circumferentially positionable on a user's head.

[0404] In one form of the present technology, the positioning and stabilising structure is formed as a flexible headband circumferentially positionable on a user's head. The eye component may be attached to at least a portion of the band along its length, or at least to a face facing portion of the band. Alternatively, the eye component may be circumferentially attached to the band along its whole length or is a portion of the circumferential band. In this regard, the positioning and stabilising structure is contiguous with the eye component such that the eye mask may be worn as a headband on a user's head when not in use.

[0405] The positioning and stabilising structure may overlay at least an otobasion superior region of the user's head in use. The positioning and stabilising structure may be configured to overlay an otobasion superior region and otobasion inferior region of the user's head in use. In this regard, the ears of the user may be covered. This may reduce noise to the user.

[0406] In one form of the present technology, a positioning and stabilising structure comprises a strap. The eye component may be attached to the positioning and stabilising structure at its ends thereof. The strap may be constructed from a laminate of a fabric user-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. Alternatively, or in addition, the strap may comprise fiberfill (for example, polyester fiberfill), non-woven padding, foam padding, high density upholstery foam, compressed polyester, medium density polyurethane antimicrobial foam, high density polyurethane foam, dry fast open cell foam, or a combination thereof. Consequently, the strap is not too large and bulky to prevent the user from lying in the side sleeping position. In addition, the strap is extensible and soft.

[0407] In one form of the present technology, the positioning and stabilising structure comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension. The positioning and stabilising structure may comprise adjustable means for extending the strap. In one form of the present technology, the positioning and stabilising structure comprises a left strap, a right strap and a connector. The connector may be a buckle.

[0408] In one form of the present technology, one or more rigidizers may be provided to selectively alter the rigidity of the positioning and stabilising structure. These may be attached to an external surface of the fabric, or inserted within the fabric layers. For example, the rigidizer may be laminated to or embedded between fabric layers. Thermoset yarns may be used to provide selective rigidification. The textile may also be rigidized at other parts of the positioning and stabilising structure, such as alongside sections that will contact the user’s face in use, for example using a coating, a laminate, a rigidized thread sewn into the textile, or any similar means.

[0409] The rigidizers may be semi-rigid. In other words, the rigidizers may be more rigid than the textile material used to form the positioning and stabilisingstructure, but not completely rigid. In this way, they are capable of providing structure to the positioning and stabilising structure, but are flexible so that they are capable of being bent. A user and / or medical professional may adjust or bend the rigidizers in order to provide tailored support for an individual user. The rigidizers also may begin semi-rigid (in other words, the rigidizers may be semi-rigid at the beginning or initially), and may become rigid after a period of time. For example, a medical professional may adjust the shape of the rigidizers so that the positioning and stabilising structure is suited for an individual user’s face. Then the rigidizers may be treated (e.g., heat treated) so that they are set in their shape. In other words, the rigidity of the rigidizers is capable of changing. Consequently, the rigidity also changes and may be selectively increased to provide tailored support for the individual user (or user).

[0410] In some forms of the present technology, the positioning and stabilising structure is bifurcated into a first section and a second section. The positioning and stabilising structure may be bifurcated at opposed ends thereof, or at a position adjacent to a temporal region of a user's head in use. The first and second bifurcated sections may jointly cradle a crown of the user's head in use. The first section may be movable relative to the second section. Alternatively, the first section and the second section is bifurcated at a fixed angle. The angle may be about 60° to about 120°.

[0411] When the positioning and stabilising structure is formed as a headband, the positioning and stabilising structure may be fabric material or composite material. The positioning and stabilising structure may be made breathable, so as to provide comfort to the user.

[0412] In one form of the present technology, the positioning and stabilising structure is configured to loop over the user's ears. The positioning and stabilising structure may have a curved morphology, such that it arcs over the otobasion superior region of the user's head and a lower occipital region. The positioning and stabilising structure may comprise a rigidiser to maintain the arc.

[0413] The positioning and stabilising structure may be formed from a material selected from perforated textile, breathable foam and / or fiber. Alternatively, a fabric composite material may be used. The composite material may be a laminated material.

[0414] In one form of the present technology, the positioning and stabilising structure is an elastic fabric material. For example, polyester, cotton, spandex, or nylon may be used, which may be further laminated with another fabric.

[0415] In certain forms the positioning and stabilising structure may include two side strap portions arranged to extend from the eye component and / or face contacting structure of the eye mask along the sides of a patient's head, and two back strap portions arranged to extend along the back of the patient's head. In some forms the two back strap portions may not be adjustable except through the elasticity of the back strap portions or through increasing the back strap portions in tightness equally by shortening the total length of the positioning and stabilising structure, the positioning and stabilising structure may comprise three, four or more separate straps connected by two or more joints and the positioning and stabilising structure may be directly connectable to the connection structure of the eye mask, such that adjusting the tightness of the positioning and stabilising structure adjusts the tightness and positioning of the patient interface components against the user’s face when in connection with the connection structure of the eye mask.4.7.7 Materials

[0416] Various materials may be used to provide a soft touch feel and comfort to the user. For example, elastomeric nonwoven may provide soft, airtight surface which may be incorporated as a material for forming the positioning and stabilising structure. The elastomeric nonwoven may further be used as a cushion material on the positioning and stabilising structure. Further, the elastomeric nonwoven may be bonded to a variety of materials which is commonly used for the eye mask.Elastomeric nonwoven provides better elastic recovery to the positioning and stabilising structure, thus providing lower deformation and longer usage. The nonwoven material is soft and flexible. The material is soft in the sense that it may give way under pressure. The material is flexible in the sense that it is capable of being flexed or bent without breaking. The nonwoven material may be formed as a layer on a user-facing side, which is an outside surface which may be in contact with the user's skin when in use. The nonwoven material may be used as is without any additional support provided by adding other more resilient materials, or may be configured to provide sufficient structural support for it to be used alone.Alternatively, the nonwoven material may be bonded to a flexible and / or resilient material for further structural support.

[0417] Elastomeric nonwoven refers to an elastomer which is formed as a fabriclike material. An elastomer is a polymer that displays rubber-like elasticity. It has both viscosity and elasticity properties, weak intermolecular forces and low Young's modulus. A nonwoven fabric is a fabric-like material made from staple fiber (short) and long fibers (continuous long), bonded together by entangling fibers via chemical, mechanical or solvent treatment. Nonwoven fabric is not woven nor knitted.

[0418] The elastomeric polymer comprises hard segments and soft segments. The hard segments provide strength and rigidity while the soft segments provide elasticity but may result in a tackiness of the fabric. A balance of hard and soft segments is required to maximise the desirable properties of both the hard and soft segments.

[0419] The elastomeric nonwoven may be melt-blown. Melt-blown nonwovens are produced by extruding melted polymer fibers through a spin net or die consisting of up to 40 holes per inch to form long thin fibers which are stretched and cooled by passing hot air over the fibers as they fall from the die. The resultant web is collected and formed as a fabric-like material. The fibers from a melt-blown process may be made extremely fine. The melt-blown fibers may also be combined with other types of elastomeric nonwoven such as staple, spunbond and / or flashspun to form a fabriclike material with different properties.

[0420] In one form of the present technology, the elastomeric nonwoven layer is formed from a thermoplastic elastomer. In one form of the present technology, the elastomeric nonwoven layer is selected from polyolefin based elastomer, co-polyester elastomer, thermoplastic polyurethane elastomer, styrenic block copolymer, or a combination thereof. The elastomeric nonwoven layer may have hard: soft segment ratio of 1 :0.1 to about 1:10.

[0421] In one form of the present technology, the elastomeric nonwoven is selected from polyether block amide (Pebax), thermoplastic elastomer ether ester (Hytrel), thermoplastic polyurethane (Elastolan), styrenic rubber block co-polymer (Kraton), or a combination thereof. In one form of the present technology, the elastomeric nonwoven is selected from polyether block amide (Pebax), thermoplastic elastomer ether ester (Hytrel), or a combination thereof. For example, Pebaxcomprises nylon 11 as the hard segment while Hytrel comprises polybutylene terephthalate as the hard segment.

[0422] In one form of the present technology, the nonwoven is calendered.Calendering of fabric is a finishing process used to smooth, coat, or thin a material. The fabric is passed between rollers at high temperature and pressures. This process flattens circular fibers on the surface and decrease inter-fiber distance and pore size of the fabric. This polishes the surface of the fabric and makes the fabric smoother and more lustrous.

[0423] In one form of the present technology, the nonwoven is bonded to the flexible and / or resilient material. The flexible and / or resilient material may be a foam. The flexible and / or resilient material may be selected from silicone, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomer, polycarbonate-acrylonitrile butadiene sytene (PC-ABS), polyethylene terephthalate (PET), or a combination thereof. The strength of the bond may be measured using ASTM SI 876-08. In one form of the present technology, the nonwoven is ultrasonically bonded to the flexible material. Alternatively, the nonwoven may be bonded to the flexible material via adhesive, lamination, thermal sealing, mechanical bonding, chemical bonding and / or welding.

[0424] Other types of fabric may also be used. For example, a knit fabric may be used, such as a cotton knit. A woven fabric may also be used. The difference between woven fabric and knit fabric is the yarn that they are composed of. Knit fabric is made of a single yarn, looped continuously to provide a braided pattern. Based on the inter looping direction, knitted fabrics may be classified as warp knitted fabric or weft knitted fabric. Knit fabric stretches easily along its width with a slightly less stretch along its length. A woven fabric is composed of multiple yarns wound at right angles to one another such that they create a criss-cross pattern. Woven fabric stretches along its length, but is less stretchable along its width. Thus, in general, knitted fabric are more flexible than woven fabric.

[0425] The knitted fabric or woven fabric may be made from a yam selected from natural and / or synthetic fibers. Examples of such fibers include, but is not limited to, cotton, wool, enset, jute, viscose, polyester, Nylon and spandex.

[0426] In one form of the present technology, the knitted fabric is a weft knitted fabric. In one form of the present technology, the knitted fabric is a warp knitted fabric.

[0427] The fabrics may be combined using techniques such as lamination, adhesive, thermal sealing, mechanical bonding, chemical bonding and / or welding.

[0428] In one form of the present technology, at least two fabrics are connected together. The fabrics may be continuously joined to each other. In this regard, one fabric transits seamlessly to another. Alternatively, the fabrics may be connected together via a seam, stitch and / or adhesive. This allows different types of fabric to be used to form the body, to achieve a variety of functionalities.

[0429] In one form of the present technology, the eye mask is formed from a spacer fabric. Spacer fabric contains a combination of two independent textile sheets interconnected with spacer yarns (forming a spacer layer) so that the fabric has a 3D appearance. The spacer fabric may comprise two knitted fabrics separated by spacer yarns. Because of the spacer yams, a defined distance may be established between the textile sheets. The textile sheets may be constructed similarly or differently to achieve a multitude of functionalities. The spacer layer may comprise monofilaments and / or multifilaments. Monofilament refers to a single solid filament. Multifilament refers to a yarn which has multiple filament fibers twisted together. While spacer fabric having monofilaments may be stiffer, can resist high pressure and may allow for directed transport of fluid and heat, spacer fabric having multifilaments allows for more movement and flexibility. Accordingly, a combination of monofilaments and multifilaments may be used. The filaments may be formed from a material selected from polyester, nylon and / or recycled yarn. Other materials include, but are not limited to, cotton, viscose, rayon, acrylic, elastane, blended yarn comprising polyester and cotton / viscose, cotton / acrylic, polyacrylic in different proportions or combinations.

[0430] In one form of the present technology, the spacer fabric is characterised by a thickness of about 2 mm to about 10 mm.

[0431] Other types of fabric may be used, such as flat, warp, large and smalldrum circular knitting, spacer mesh, and quilt with filler. Any material used to fabricate fabric may be used. For example, the material may be selected from virginand / or recycled polyester, polypropylene, polyamide, various spandex or stretch materials, poly(lactic acid), wool, cotton, bamboo, jute, or a combination thereof. In one form of the present technology, the material is an elastic material.

[0432] In addition to fabric materials, other materials such as fabric fiberfill (for example, polyester fiberfill), non-woven padding, foam padding, high density upholstery foam, compressed polyester, medium density polyurethane antimicrobial foam, high density polyurethane foam, dry fast open cell foam, or a combination thereof may also be used to provide support and comfort to the user.4.8 EMBODIMENTS OF THE TECHNNOLOGY

[0433] Some embodiments of the present technology are described below.

[0434] FIG. 6 shows a user wearing an eye mask 7000 of the present technology as a component of patient interface 8000, with FIGs. 8 to 11 showing the patient interface 8000 in a connected or disconnected configuration. The eye mask 7000 comprises an eye component 7010 positioned over at least orbital regions of a face of a user. The orbital region includes a supra-orbital region. The eye component 7010 is further positioned over a portion of an infra-orbital region of the user. The eye component 7010 is configured to block light to the eyes. The eye component 7010 is further positioned over a portion of a nasal region of the user. The eye component 7010 is further positioned over a portion of a zygomatic region of the user. The eye mask 7000 comprises a face-contacting structure 7020 connected to the eye component 7010 on the user-facing side of eye mask 7000. The face-contacting structure 7020 is constructed and arranged to engage the user's face. This prevents stray light from entering the inner space of the eye mask 7000 and to the eyes. A positioning and stabilising structure 7600 is attached to the eye component 7010 and / or face-contacting structure 7020 for attaching the eye mask 7000 to the user's face. The positioning and stabilising structure 7600 may be laminated to the eye component 7010. The positioning and stabilising structure 7600 may be formed as an elastic headband. This may provide additional support to prevent displacement of the eye mask 7000 during use.

[0435] Connection structure 7888 (See also FIG. 7) is located on the medial inferior edge of eye mask 7000 and may be formed as a single component such as frame portion 7800, or may comprise multiple components configured together. Insome forms the components are fixedly connected, and in other forms the components may be releasably connected. In one form the connection structure comprises a connection mechanism to enable releasable attachment of frame portion 7800 to the eye mask via the connection mechanism. The connection mechanism may comprise a sleeve, clip-fit or interlock mechanism for example. Connection structure 7888 in one form comprises frame portion 7800 and arm portions 7804 extending from opposing lateral edges of frame portion 7800, frame portion and arm portions over molded within the face-contacting structure 7020 and / or eye component 7010 and held substantially rigidly in position.

[0436] In some examples described below with reference to the figures, connection structure 7888 comprises frame portion 7800 integrally formed with facecontacting structure 7200 and / or eye component 7010. However, it should be understood that in further embodiments, the connection structure may be formed of multiple components, such as a frame portion, sleeve, connection mechanism, and frame portion 7800 may be removably received by other components of connection structure 7800, allowing frame portion 7800 to be utilized or not as required by the user.

[0437] FIG. 7 and 8 show a user facing side of eye mask 7000 in one form of the technology, with cut-away region showing the connection of frame portion 7800 to the eye mask shown in dashed lines.

[0438] In one form as shown in Figure 7, the cut away area as indicated in dashed lines shows the inner structure of the eye mask wherein the connection structure 7888 comprising a frame portion 7800 and arm portions 7804, molded within raised wall portions 7026 extending along the inferior wall of eye mask 700. Fram portion 7800 is molded in position within the eye mask along a superior edge of the frame portion 7800, such that the frame body extends below the inferior edge of eye mask 7000. This positioning allows for easy connection of a cushion assembly or other component of an RPT air circuit to the frame portion, without affecting the light blocking ability of the mask and ensuring the air circuit is correctly locatable around the nasal region of the user.

[0439] Face-contacting structure 7020 forms the posterior face of eye mask 7000 and comprises at least one cavity 7300 configured to space the eye component apartfrom the eyes of the user. The face-contacting structure 7020 further comprises a bridge portion 7400 for stabilising the eye mask 7000 and cushion assembly 8300 on a nasal region of the user's face. A positioning and stabilizing structure 7600 may be fixedly or releasably connectable at opposing lateral edges 7295 / 7290 of the facecontacting structure 7020 and / or eye component 7010, via flanges formed in the eye mask structure (see Fig. 8) and extend around a user’s head to keep the eye mask and cushion assembly 8300 in position on the user’s face.

[0440] Face-contacting structure 7020 comprises a wall 7021 extending from a base portion 7060 of the cavity 7300 to the user-facing surface of the face-contacting structure 7020. Wall 7021 may fully or partially extend around the perimeter of cavity 7300, creating a raised surface for abutting the user’s face and maintaining a space for the user’s eyes within cavity 7300.

[0441] Wall 7021 comprises a first side wall portion 7090 extending from the perimeter of the base portion 7060 of the cavity 7300 to the user-facing surface of the face-contacting structure 7300 and a second side wall portion 7091 opposing and spaced apart from the first side wall portion closer to the perimeter of the eye mask than the first side wall portion 7090 and extending towards the user-facing surface, the first and second side wall portions are spanned by a user-facing surface wall portion 7093.

[0442] The wall 7021 around or partially around the perimeter of cavity 7060 may vary in height, width, depth, texture, compressibility at different regions in order to ensure a snug fit on the user that maintains light-blocking and ensures frame portion 7800 is presented at an effective angle for attachment to components of a respiratory pressure therapy system.

[0443] Wall 7021 comprises a superior raised wall section 7022 that extends laterally across the superior edge, or proximate the superior edge of the eye mask 7000. As with wall 7021, the superior raised wall section comprises the first side wall portion 7090 extending from the perimeter of the base portion 7060 of the cavity 7300 to the user-facing surface of the face-contacting structure 7300 and a second side wall portion 7091 opposing and spaced apart from the first side wall portion closer to the perimeter of the eye mask than the first side wall portion 7090 and extending towardsthe user-facing surface, the first and second side wall portions are spanned by a userfacing surface wall portion 7093.

[0444] When compared to other regions of wall 7021, superior raised wall section 7022 has a broader user-facing surface wall portion 7093 to provide a wide engagement region over the user’s forehead. This additional engagement surface improves the light-blocking ability of the mask, and the increased engagement between forehead and mask increases friction and aids in retaining the eye mask in a fixed position. When used as part of a patient interface, the position of the eye mask on the face can influence how effectively a respiratory pressure therapy system works, the seal between the nose and the cushion assembly, and subsequently this can affect patient compliance and effectiveness of the respiratory treatment. The positioning of the eye mask and retention of that position over the course of a sleep session may influence the overall success of the patient interface.

[0445] Superior raised wall section 7022 may be configured such that when the eye mask is in position on a user’s face, the superior-inferior axis of the anterior surface of the eye component 7010 is between 0 - 30° either side of vertical. This configuration may be achieved by increasing the distance between the base of the cavity and the user-facing surface portion 7093 of the superior raised wall section 7022, allowing for an adjustment of the angle at which a nasal cushion is received at the connection structure. For example, creating an angle between the anterior surface of the eye mask level with the superior raised wall section 7022 (e.g. against a patient’s forehead), and the anterior surface of the eye mask level with the inferior raised wall section (e.g. against the patient’s cheeks and / or nasal bridge) of any one of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 2728, 29, 30, 31, 32, 33, 34, 35° from vertical, may enable a better seal between the cushion assembly and the user’s face. The eye mask may be held snugly in this position using the positioning and stabilising structure of the eye mask which provides a rearward force with a single vector to achieve an effective seal.As the anatomical structure of faces differ across populations, eye masks having a range of different configurations that allow for a range of contact angles to a user’s face may be useful. This angle may also be altered by interchanging functional modules within the cavity of the eye mask, to change the contact angle of the nasal cushion against the user’s face.

[0446] As well as having a comparatively larger surface area compared to the remaining wall 7021, the outer surface of the user-facing wall portion 7093 of superior raised wall section 7022 may be adapted to increase the friction between the user’s forehead by inclusion of a gripping material 7070 such as silicone, or polished silicone. Increasing friction allows for increased stability of the eye mask and subsequently the position and effectiveness of a connected nasal mask on the user’s face, particularly during sleep when a user may move around significantly. This may extend over the entire region user-facing wall portion 7093 of the superior raised wall section, or may be applied with a pattern, in discrete regions, or with different thicknesses, as discussed in further detail above. As seen in FIG. 11, the outer surface of the user-facing wall portion may extend around the lateral edges of the facecontacting structure of the eye mask to further improve secure positioning on the user’s face.

[0447] The gripping material 7070 may be removable and washable, or may be incorporated into the textile of the eye mask.

[0448] In certain forms, the wall 7021 comprises an inferior raised wall section 7023 extending along or partially along an inferior edge of the cavity, and / or proximate to, or on the inferior edge 7088 of the eye mask. As with the superior raised wall section, the inferior raised wall section comprises the first side wall portion 7090 extending from the perimeter of the base portion 7060 of the cavity 7300 to the userfacing surface of the face-contacting structure 7300 and a second side wall portion 7091 opposing and spaced apart from the first side wall portion closer to the perimeter of the eye mask than the first side wall portion 7090 and extending towards the userfacing surface, the first and second side wall portions are spanned by a user-facing surface wall portion 7093.

[0449] Inferior raised wall section 7023 may curve around bridge portion 7400, providing a snug seal to the face. The superior and inferior raised wall sections are connected by opposing lateral edge wall sections 7024 together defining a perimeter of the cavity 7300.

[0450] The gripping material 7070 may extend across the lateral edge wall sections 7024, or the inferior raised wall section 7023 partially or entirely as required.

[0451] Frame component 7800 is mounted on the inferior edge of eye mask 7000 and provides a connection point for a cushion assembly 8300 and connection port 8100, such that when these components are connected to frame portion 7800, the eye mask is a patient interface for use with a respiratory therapy system. The position of the frame portion 7800 enables the attachment of an air conduit that will extend down from the eye mask, towards the chin of the user. In forms shown, frame portion 7800 is connected within the bridge portion 7400, such that the cushion assembly 8300 and connection port 8100, when connected, fit snugly over the user’s nose region and are neatly mounted within the bridge portion of the eye mask.

[0452] Frame portion 7800 is mounted such that inferior raised wall portion 7023 extends around the bridge portion 7400 and a superior edge of frame portion 7800, with the user facing surface wall portion 7093 narrowing around the frame and bridge portions compared to the remaining inferior raised wall section, such that light blocking ability of the mask is retained and any sharp or angled surfaces associated with the frame portion are eliminated, providing comfort to the user. A region of the frame portion 7800 may be retained within the inferior raised wall section during manufacture as part of the mask construction.

[0453] With frame portion 7800 mounted centrally along the inferior edge of eye mask 7000, the inferior raised wall section comprises two raised wall sections 7026 / 7027 spaced apart along the lower edge of the eye mask to define a space therebetween where frame portion 7800 is mounted, with each of the two raised wall section 7026 / 7027 configured to abut opposing sides of the frame portion.

[0454] In some forms, the two raised wall sections 7026 / 7027 comprise air pockets for increasing the light-blocking ability of the eye mask when a nasal cushion is connected to the frame portion. The air pockets allow for added compression and flexibility of shape of the walls directly next to the frame portion, such that they can change to accommodate different sized nasal cushions, and also as the user moves during sleep. The air pockets may be one or more discrete air pockets that can compress independently of one another, for example two or three formed within each of the raised wall portions 7026 / 7027, or there may be one or two elongate air pockets that allow compression of the wall across a wider region.

[0455] In some forms the first and second wall portions 7091, 7090 of the two raised wall sections 7026 / 7027of the inferior raised wall section 7023 adjacent the frame portion 7800 extend further from the base 7060 of the cavity 7300 than the first and second wall portions 7091, 7090 of the first and second raised wall portions distal from the frame portion 7800, increasing the light-blocking ability of the eye mask around the frame portion when a nasal cushion assembly 8300 is connected to the frame portion.

[0456] Frame portion 7800 comprises a frame body 7801. In some forms, the frame body 7801 is an irregularly hemispherical frame body, having a concave inner surface and a concave outer surface

[0457] Frame body 7801 is shaped to define the perimeter of a circular aperture in the concave base of the frame body 7810 for releasably receiving a connection port 8100. Connection port 8100 may pass through aperture 7810 and connect directly to cushion assembly 8300 via a first connection member, or may connect directly to the frame body 7800 at or around the perimeter of aperture 7810.

[0458] Frame body 7810 comprises curved side walls, the curved side walls comprising at least one second connection member 7809 configured to releasably receive a cushion assembly 8300. In some forms, the second connection members 7809 are located on the concave surface of the curved side walls and are configured for connection to the plenum chamber 8320 of cushion assembly 8300 to the posterior side of frame portion 7800.

[0459] Frame body 7801 may comprise opposing arm portions 7804 for facilitating connection of the frame body 7801 to the face-contacting structure and / or eye component. The arms may extend 10mm - 50mm from opposing sides of the frame portion 7801 and may be integrally formed or overmolded with the frame portion 7800 and optionally extend from a superior region of the frame portion.

[0460] Frame body 7801 may be positioned on the eye mask at or near the medial inferior edge of the eye mask such that the concave inner surface of the frame body faces the user when the eye mask is in position on the user’s face. At least a portion of the frame body 7801 may extend below the inferior edge of the eye mask when mounted in position, or the frame portion may be positioned on the eye mask such that the frame body does not extend below the inferior edge of the eye mask.

[0461] The at least one second connection member 7809 may comprise a male or female portion of quick fit mechanism, interlocking mechanism, magnetic connection mechanism or snap lock mechanism to releasably receive cushion assembly 8300.

[0462] Patient interface 8000 as seen in Fig. 8, 9 and 10 comprises eye mask 7000 as described above, together with cushion assembly 8300, which comprises plenum chamber 8320 and seal forming structure 8350 in the form of a nasal cushion which enables use of the eye mask with an RPT system. Cushion assembly 8300 connects to the posterior side of frame portion 7800, such that in use, the nasal cushion seals around a portion of the user’s nose, including the nares portions, enabling the delivery of positive pressure air flow to the user’s nostrils, with the frame portion 7800 supported in an effective position by eye mask 7000. The angle at which the nasal mask connects to the eye mask can alter the performance of the seal of the cushion assembly with the user’s face, as discussed further above.

[0463] Connection port 8100 in the form of an elbow joint is releasably connected to the cushion assembly from the anterior side of frame portion 7800 through aperture 7810 in a base portion of frame portion 7800. Connection port 8100 is connectable to an air conduit 8200 of an air circuit of an RPT system, such that when connected, the patient interface 8000 allows the patient to breathe positive pressure air through their nose via the patient interface, while also benefiting from the light-blocking features of eye mask 7000.

[0464] The eye mask 7000 may be configured such that when cushion apparatus 8300 is connected to frame portion 7800, only 10 - 50% of the cushion apparatus is visible beneath the eye component of the eye mask 7000, when viewed directly face on and the eye mask is in position on a user’s face.

[0465] FIG. 11 shows a further embodiment of the patient interface 8000 showing eye mask 7000 where superior raised wall section 7022 and a portion of lateral edge wall sections 7024 are formed with a comparable cross sectional shape and comprise a gripping surface around both the superior raised wall section 7022 and lateral edge wall sections 7024 on at least the user-facing surfaces. In the embodiment of Fig. 11, superior raised wall section 7022 and a portion of lateral edge wall sections 7024 are formed from a silicon molding with a central foam core.

[0466] FIG. 12, 13 and 13E show an eye mask 30000 in a further form, with facecontacting structure 30200 shaped to comprise a recess 30300 and cavity 30400. Recess 30300 is configured to be positioned on the eye mask superior to and centrally aligned with cavity 30400, proximate top of eye mask 30000.

[0467] Recess 30300 is configured to house a functional module and cavity 30400 is configured to surround a user’s eyes, providing space for eye movement and blinking, without risk of the user’s eyelashes touching inner surface 30229 when the mask is in position on the user’s face.

[0468] In some forms, each of recess 30300 and 30400 is defined or partially defined by a wall 30201 formed as part of face-contacting structure 23000, and optionally as part of eye component 30100. Wall 30201 extends from a base portion of recess 30300 and cavity 30400 to the user facing surface 30229. In some regions around the perimeter of either recess 30300 and / or recess 400, wall 30201 converges into a flat region of user-facing surface 30229, for example flat regions 30241 A and 30242 A of user-facing surface 30229 adjacent side wall sections 30241 and 30242 respectively of recess 30300.

[0469] In other regions of the face-contacting structure, wall 30201 is formed to create raised wall sections that comprise a user-facing surface wall portion 30215 bridging a first side wall portion 30216 extending between base portion of recess 30300 and / or 30400 and user facing surface wall portion 30215, and an opposing second side wall portion 30217. Second side wall portion 30217 may vary in height depending on the position on the face-contacting structure. For example, a second side wall portion 30217 may form part of the outer edge of the eye mask, such as over the nasal region, or along the top 30001 of eye mask 30000. In other regions, second side wall portion 30217 may form part of an internal wall structure surrounding recess 30300 and or 30400, therefore the height of second side wall portion at these regions may be less than the height of the second side wall portion near an edge of the eye mask 100. In some forms, recesses 30300 and 30400 share a wall, such that the first side wall portion 30216 of recess 30300 may be the second side wall portion 30217 of cavity 30400 and vice versa.

[0470] As seen in FIG. 12, recess 30300 comprises base portion 30320, the perimeter of base portion 30320 defined by first side wall portion 30216 of wall30201. Base portion 30320 of recess 30300 is formed such that the recess 30300 is positionable over the supra orbital and / or frontal bone / glabella region of the face of the user when the eye mask is in the use position.

[0471] Base portion 30320 of recess 30300 is an elongate polygon or rounded elongate polygon shape with the long axis of the elongate polygon oriented substantially parallel to the top 30001 and bottom 30002 of eye mask 30000, and sized to substantially traverse at least between the left and right supraorbital foramen and / or span the central region of the frontal bone of a user's head in use.

[0472] Recess 30300 is shaped to receive or partially receive, and connect with, a functional module 30500, which may be sized to provide additional cushioning and support to maintain the eye mask in an effective position on a user’s face to enable effective use of an RPT system through the connection of a cushion assembly and air conduit to frame portion 7800.

[0473] In one form the wall 30201 of the recess 30300 comprises a superior raised wall section 30240 extending laterally in along a top edge of the recess 30300, proximate the top 30001 of the eye mask. Superior raised wall section 30240 comprises a first side wall portion 30216 and a second side wall portion 30217 opposing the first side wall portion 30216, the first and second side wall portions spanned by a user-facing surface wall portion 30215.

[0474] An intermediate raised wall section 30250 spaced apart from the superior raised wall section 30240 extends laterally along a bottom edge of the recess 30300, more distal from the top edge 30001 of the eye mask 30100 than the superior raised wall section 30240. Intermediate raised wall section 30250 comprises a first side wall portion 30216 and a second side wall portion 30217 opposing the first side wall portion 30216, the first and second side wall portions spanned by a user-facing surface wall portion 30215. Superior raised wall section 30240 and intermediate raised wall section 30250 are indirectly connected to each other at either end by side wall sections 30241 and 30242. Together, wall sections 30240, 30241, 30242 and 30250 form the boundary of recess 30300.

[0475] Superior raised wall section 30240 extends away from the base portion 30320 of recess 30300 further than the intermediate raised wall section 30250, bringing the user-facing surface wall portion 30215 of first raised wall section 30240closer to the user’s face than the user facing wall portion 30215 of the second raised wall section 30250, when the mask is in position on the user’s face. The reduced height of intermediate raised wall section 30250 in comparison to first raised wall section 30240 may allow optional effects produced by functional module 30500 to reach the user’s eyes. For example, functional module 30500 may comprise a light therapy component, and the comparatively reduced height of second raised wall section 30250 may allow light from functional module 30500 to enter cavity 30400 and subsequently the user’s eyes. In addition, having first raised wall section 30240 extend further from base portion 30320 than second raised wall section 30250 may improve retention of the functional module 30500 within recess 30300 as the user puts on the eye mask 30000. When the mask is being lowered into position from above the forehead, an upwards force is applied to function module 30500, and functional module 30500 is prevented from rotating or moving out of position by abutment with first raised wall section 30240. Further the reduced height of the intermediate raised wall section allows for an increase in the size of the functional module, which may in turn further stabilise the eye mask, such that any connected components of the RPT system are maintained in an efficacious position.

[0476] In some forms, the first side wall portion 30216 and / or second side wall portion 30217 of the intermediate raised wall section 30250 are variable in height along the length of the second raised wall section 30250.

[0477] The size and shape of the different wall sections of face component 30200 may vary across different eye masks to suit the facial profiles of particular population groups, for example by accounting for different forehead slopes / nasal bridge sizes. The heights of walls 30201 at different regions within the mask may change relative to each other to ensure optimum light blocking and comfort for the user.

[0478] In one form the wall 30201 comprises / is formed from both a curved / shaped posterior surface of eye component 30100 and a complementary shaped / curved face-contacting structure 30200. In other forms, the wall comprises / is formed from a shaped / curved face-contacting structure 30200 connected to a substantially flat posterior surface of the eye component 30100.

[0479] The recess 30300 may be characterised by a depth from the base portion of the recess to the user-facing surface 30229, the depth of the recess may beconfigured by varying the height of the walls 30201 of face-contacting structure 30200.

[0480] In some forms, base portion 30420 of cavity 30400 is defined or partially defined by a wall 30201 formed as part of face-contacting structure 30200, and optionally as part of eye component 30100. In use, cavity 30400 covers both the left and right eyes and wall 30201 surrounding recess base 30420 is configured to contact at least the orbital regions of the user's face.

[0481] In one form of the present technology, the cavity 30400 is defined along its top edge by intermediate raised wall section 30250 extending laterally along a portion of, or all of a top edge of cavity 30400. Intermediate raised wall section 30250 forms a raised wall section that forms a lateral boundary between recess 30300 and cavity 30400.

[0482] Intermediate raised wall section 30250 comprises a first side wall portion 30216 and a second side wall portion 30217 opposing the first side wall portion 30216, the first and second side wall portions spanned by a user-facing surface wall portion 30215.

[0483] Cavity 30400 is defined along a bottom edge proximate bottom edge 30002 of eye mask 30000 by inferior raised wall section 30270 on the opposing side of cavity 30400 from intermediate raised wall section 30250, inferior raised wall section 30270 comprising a first side wall portion 30216 extending from the recess base 30420 and a second side wall portion 30217 opposing the first side wall portion 30216, the first and second side wall portions spanned by a user-facing surface wall portion 30215.

[0484] Intermediate raised wall section 30250 and inferior raised wall section 30270 may vary in height along their length, with a change in the height of first side wall portion 30216 resulting in a corresponding change of recess depth. In one form the change in recess depth provides for a deeper recess around the eye region of the user that tapers to a shallower recess near the side edges 30271, 30272 of cavity 30400 for example.

[0485] Face-contacting structure 30200 is configured to contact or surround an area of the face defined by the supra-orbital region, infra-orbital region and nasal region of the user’s face such that cavity 30400 provides a region that cover’s theuser’s eyes, with at least apportion of wall 30201 providing a seal against the user’s face to block light.

[0486] In some forms the perimeter of recess base 30420 defined by inner wall portions 30216 has a curved shape that mimics two fluidly connected orbital eye regions. In some forms, recess base 30420 may be shaped to mimic two non-fluidly connected orbital eye regions, the two regions separated by a raised region in the recess base 30420, or an extended section of second or third raised wall sections configured to separate the cavity 30400 into two regions.

[0487] In some forms, the perimeter shape of recess base 30420 is a kidney shape or cassian oval shape. In other forms the perimeter shape of the recess base 30420 substantially mimics the perimeter shape of eye component 30100 of part thereof.

[0488] The cavity 30400 may be characterised by a depth from the base portion 30420 of the cavity 30400 to the user-facing surface 30229 or user-facing surface wall portion. The depth of the recess may be configured by varying the height of the walls 30201 of face-contacting structure 30200.

[0489] The face-contacting structure 30200 may further contact a portion of a nasal region of the user. In this regard, the face-contacting structure may overlap a nose bridge region or on a nose-ridge region of the user's face.

[0490] As seen in at least FIG 13, in some forms the centre of bottom region 30002 of eye mask 30000 includes a bridge portion 30700. Bridge portion 30700 is formed by the face-contacting structure 30200 and optionally, eye component 30100. In some forms, both eye component 30100 and face-contacting structure 30200 are shaped to include a nasal curve 30710, nasal curve 30710 curving around the anterior / posterior axis of the eye mask 30000 to accommodate the nasal bridge of a user. Nasal curve 30710 ensures the eye mask 30000 sits comfortably on the user’s nasal bone in use, rather than pressing against the softer cartilage region of the nose.

[0491] In one form, the bridge portion 30700 comprises inferior raised wall section 30270 and is connected to the eye component 30100 by an end of the first side wall portion 30216 of the wall 30201 distal from the user-facing surface wall portion 30215 of the wall 30201 and by an end of the second portion of the wall 30217 distal from the user-facing surface wall portion 30215 of the wall. In this form, an inferior raised wall portion is curved to conform to the nasal region of a user.

[0492] To improve comfort and light-blocking ability, bridge portion 30700 may comprise a compressive region 30720 between the face-contacting structure and the eye component 30100. In some forms where the bridge portion 30700 includes an inferior raised wall section 30270, first side wall portion 30216, user-facing portion 30215 and second side wall portion 30217 of inferior raised wall section 30270 are formed from material having a thickness such that when first and second side wall portions are connected to the posterior surface 30105 of eye component 30100, the compressive region 30720 is formed in the space defined by the first and second side wall portions 30216, 30217, user-facing portion 30215 and posterior surface 30105 of eye component 30100.

[0493] In one form, the compressive region is an air-pocket 30288 and the inferior raised wall section 30270 is deformable. In use, a force applied to the inferior raised wall section 30270, for example when the inferior raised wall section 30270 is pressed against the nasal region of a user, the air pocket 30288 is compressed, allowing the inferior raised wall section 30270 to conform to the user’s nasal region shape.

[0494] In other forms, the inferior raised wall section 30270 encases a compressible or deformable member, the member encased by the first side wall portion 30216, second side wall portion 30217, user-facing surface wall portion 30215 and the posterior surface of the eye component 30105. The compressible or deformable member may extend the length or part of the length of the inferior raised wall section 30270. In other forms the compressible or deformable member may be an open cell foam, closed cell foam, low density foam, memory foam, or an amount of gel or beads.

[0495] In one form, the inferior raised wall section 30270 or part thereof may be formed from a compressible material or combination of compressible materials to provide a comfortable engagement around the nasal region.

[0496] In one form, the inferior raised wall section 30270 is adapted to enable a change of the cross-sectional shape of the third raised wall section 30270 from a first undeformed cross-sectional shape when the eye mask is not in use to a second deformed cross-sectional shape when the eye mask is in use and held against the user’s face under force from the positioning and stabilising structure. In FIG. 13F aforce is applied in direction X against user-facing surface wall portion 30215. First and second side walls 30216 and 30217 each compress and the bridge portion 30700 forms a tight seal across the user’s nasal area, blocking light and providing a comfortable cushion surface to absorb changes in the user’s movement, for example when sleeping or lying with the mask on.

[0497] In some forms the compressive region 30720 is in the form of an air pocket 30288. In other forms, the compressive region 30720 may include a compressible or deformable member or material. The presence of one or more air-pockets or a compressible / deformable material in compressive region 30720 allows first and second side wall portions 30216, 30217 and / or user-facing portion 30215 of inferior raised wall section 30270 to compress into a range of different shapes depending on where pressure is imparted on the bridge portion 30700. This flexibility may cater for a wider range of different face shapes, and may also accommodate different sleeping positions and pressures placed on the eye mask from different directions.

[0498] Frame portion 30999 is mounted on or proximate the inferior edge of eye mask 30000 and comprises a frame body 30998. In some forms, the frame body 30998 is an irregularly hemispherical frame body, having a concave inner surface and a concave outer surface.

[0499] Frame body 30998 is shaped to define the perimeter of a circular aperture 30997 in the concave base of the frame body 30998 for releasably receiving a connection port (such as connection port 8100 seen in FIG 7, or connection port 3600 of Fig. 3A, 3B)). The connection port may pass through aperture 30997 and connect directly to cushion assembly (such as cushion assembly 8300 seen in Fig. 6) via a first connection member, or may connect directly to the frame body 30998 at or around the perimeter of aperture 30997.

[0500] Frame body 30998 comprises curved side walls, the curved side walls in some forms comprise at least one second connection member 30996 configured to releasably receive a cushion assembly. In some forms, the second connection members 30996 are located on the concave surface of the curved side walls and are configured for connection to the plenum chamber of cushion assembly 8300 to the posterior side of frame portion 30999.

[0501] Frame body 30998 may be positioned on the eye mask 30000 at or near the medial inferior edge of the eye mask such that the concave inner surface of the frame body 30998 faces the user when the eye mask is in position on the user’s face. At least a portion of the frame body 30998 may extend below the inferior edge of the eye mask when mounted in position, or the frame portion 30999 may be positioned on the eye mask such that the frame body 30998 does not extend below the inferior edge of the eye mask.

[0502] The at least one second connection member 30996 may comprise a male or female portion of quick fit mechanism, interlocking mechanism, magnetic connection mechanism or snap lock mechanism.

[0503] FIG. 13A and 14B show the formation of eye component 30100 in one example, where a laminate of textile 30910 and foam 30920 form the anterior surface 30101 and posterior surface 30105 of eye component 30100. The laminate may be formed as a flat or curved member and may be thermoformed to create a member having an overall curvature, such that anterior surface 30101 is convex and posterior surface 30105 concave. Posterior surface 30105 may be configured to include further regions of layered or shaped foam that create curved profile or raised features on posterior surface 30105 such as seen in FIG. 13C. In some forms, foam 30920 and textile 910 may be layered and shaped to create walls that create or define recesses 30300 and 30400 for example. Multiple layers of foam and / or textile may be used to create the profiles required.

[0504] In one form of the present technology, the eye-component 30100 is constructed from a composite material. The composite material may comprise an external fabric (or fabric composite) layer 30910 surrounding or mounted on one side of an inner foam 30920. The fabric layer may be thermoformed with the foam. For example, the fabric may be laminated to one or all sides of foam and placed in a 2-piece mold. Heat and pressure are then applied, which permanently molds the laminate into a semi-rigid product. The foam may be a memory foam, high density foam, low density foam, or a combination thereof. The foam may be selected from silicone, polyester, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomer, polycarbonate-acrylonitrile butadiene styrene (PC-ABS), polyethylene terephthalate (PET), latex, or a combination thereof. For example, memory foam may be used, which comprises polyurethane withchemicals that increase its viscosity and density. It is often referred to as "viscoelastic" polyurethane foam, or low-resilience polyurethane foam (LRPu).

[0505] An outer textile layer 30915 can be seen in FIG. 13B on the anterior surface 30101 of the eye component. In some forms, the textile layer 30915 may be connected around the periphery of the mask to the eye component and / or facecontacting structure, allowing the textile covering the anterior surface 30101 of eyecomponent 30100 to move freely. In some forms, outer textile layer 30915 is a smooth knit or stretch fabric and provides a flexible, crease-resistant outer surface that is both attractive and / or has light-blocking characteristics.

[0506] FIG.14B shows textile 30910 and foam 30920 comprise the shaped eyecomponent 30100, bonded directly to shaped face-contacting structure 30200 using heat-press bonding using a hot-melt adhesive for example. Other adhesives such as polymer-based adhesives, thermoset adhesives, pressure adhesives for example may be used. The final bonding process between components and / or layers can retain detail and the required geometry into the final eye mask product.

[0507] In one form the eye component and face-contacting structure are connected together at a seam or connecting edge and the seam or connecting edge is biased towards the anterior side of the mask, to prevent the seam resting uncomfortably against the user’s face when eye mask 30000 is in use, or causing marks of indentations on the user’s skin due to the connecting edge. In some forms the seam of connecting edge is formed on the first or second side portion of the wall to prevent contact with the user’s face.

[0508] Construction of face-contacting structure 30200 in one form of the technology can be seen in FIG. 13E, where face-contacting structure 30200 comprises a base material 30920 and a user-facing material 30925. Face-contacting structure 30200 is shaped to correspond or partially correspond to the curvature of the posterior surface 30105 of eye-component 30100. Thermoformed face-contacting structure 30200 comprises walls 30201 and may include compressive region 30720 around bridge portion 30700, walls 30201 sized and shaped to create nasal curve 30710 that extends over the user’s nasal region. In other forms, face-contacting structure 30100 may be formed from a single material, or may be formed with multiple layers and / or combinations of different materials as discussed further below.

[0509] In one form of the present technology face-contacting structure 30200 is created as a thermoformed textile or textile laminate component, or the facecontacting structure is constructed from a biocompatible material, e.g. silicone rubber. The face-contacting structure may be constructed from a soft, flexible, resilient material such as silicone. The face-contacting structure may be constructed from a breathable foam. The foam may have a thickness of about 1 cm to about 10 cm. The face-contacting structure may have a gradient of decreasing thickness towards an orifice configured to house an eye of the user in order to improve the breathability of the eye mask. The face-contacting structure may further be perforated to increase the breathability of the eye mask.

[0510] In other forms of the present technology, the face-contacting structure is constructed from a perforated, light blocking fabric material or composite material. The face-contacting structure may be made breathable, so as to provide comfort to the user. The face-contacting structure may be formed from a material selected from perforated textile, breathable foam and / or fiber. Fabrics that are naturally thick and dense may also be used, such as velvet, heavy cotton, or woven jacquard. These fabrics have a tighter weave or a heavier weight, which helps to minimise the amount of light that can penetrate the material. Alternatively, a fabric composite material may be used. The composite material may be a laminated material.

[0511] In some forms of the present technology, the face-contacting structure is formed from an elastic fabric material. For example, polyester, cotton, spandex, or nylon may be used, which may be further laminated with another fabric to increase its light blocking property. The fabric may be a non-woven, or may have moisture-wicking properties.

[0512] In one form of the present technology, the face-contacting structure is constructed from a composite material. The composite material may comprise an external fabric (or fabric composite) layer surrounding an inner foam. The fabric layer may be thermoformed with the foam. For example, the fabric may be laminated to one or all sides of foam and placed in a 2-piece mold. Heat and pressure are then applied, which permanently molds the laminate into a semi-rigid product. The foam may be a memory foam, high density foam, low density foam, or a combination thereof. The foam may be selected from silicone, polyester, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomer,polycarbonate-acrylonitrile butadiene styrene (PC-ABS), polyethylene terephthalate (PET), latex, or a combination thereof. For example, memory foam may be used, which comprises polyurethane with chemicals that increase its viscosity and density. It is often referred to as "viscoelastic" polyurethane foam, or low-resilience polyurethane foam (LRPu).

[0513] The foam used for the eye mask 7000 may have a cell structure that reacts to body heat and weight, helping relieve pressure points, preventing pressure sores, and the like. The density and layer thickness of the foam may provide a different feel to the user. A high-density foam may have better compression ratings over the life of the eye mask. A lower-density one will generally have slightly shorter life due to the compression that takes place after repeated use. Cell structures can vary from very open to almost closed cell. The open cell foam structure includes a plurality of interconnected cells, wherein the windows between the adjacent cells are broken and / or removed. In contrast, a closed cell foam has substantially no interconnected cells and the windows between the adjacent cells are substantially intact. The tighter the cell structure, the less airflow through the foam. Breathable foam will have a more open cell structure, allowing higher airflow, better recovery, and lower odour retention.

[0514] In further examples of the technology, the connection structure of the eye mask 9000 may be configured to enable connection of a nasal cradle as seen in FIG.3B and 3C inferior to the eye mask, as seen in FIG. 14A. In this example, FIG. 14A shows a user wearing an eye mask 9000 of the present technology as a component of patient interface 10000, with FIG. 3B and 3C showing components of the patient interface 10000 in a disconnected configuration.

[0515] As seen in 14A, eye mask 9000, which may comprise any features or combination of features as described above with respect to eye mask 7000 or eye mask 30000, is connectable at or proximate the inferior edge of eye mask 9000 to a frame portion 3307, frame portion 3307 comprising a frame body 3310 and a pair of symmetrically disposed rigidiser arms 3302, extending from opposing sides of frame body 3310. A cushion assembly 3150 (FIG.3B) comprising a plenum chamber 3200 and a seal forming structure 3100 to seal against the user’s nasal region and or / nares is connectable to the posterior surface of frame body 3310, the cushion assembly 3150 optionally covered in use by an optionally removable cover member 9400.

[0516] Cover member 9400 may be formed from a flexible textile material and shaped to cover some or all of a nasal cradle, nasal cushion, frame body 3310 and / or cushion assembly 3150. In the form shown in FIG. 14A, cover member 9400 is formed from a flexible, opaque material, connectable to the exterior surface of eye component 9010 of eye mask 9000 and frame body 3310 and / or cushion assembly 3150. In one form, cover member 9400 is shaped with a symmetrical bell shape, cover member 9400 provides light-blocking and visual coverage of the region between the inferior edge of eye mask 9000 and nasal cradle 9500.

[0517] Rigidiser arms 3302 extending from opposing sides of frame body 3301 may be received within connection structures 9888 of eye mask 9000 (FIG. 14B) to form a patient interface for use with a RPT system. Connection structures 9888 are in the form of elongate sleeves formed along, within or proximate the inferior edge of eye mask 9000. Rigidiser arms 3302 may comprise one or more protrusions 3303 to aid connection or fastening to connection structure 9888, for example by insertion within slit or buttonhole 9658 formed within sleeve 9650.

[0518] FIG. 14B and FIG. 14C shows a posterior view of the patient interface 10000 in one form of the technology, demonstrating the partial (FIG. 14B) and full (FIG. 14C) attachment of a nasal cradle mask comprising cushion assembly 3150, frame body 3310, rigidiser arms 3302, extension members 3350 and air conduit 3361 to eye mask 9000.In the form shown in Fig. 14B, the connection structures 9888 are in the form of two elongate sleeves 9650, formed from a flexible material as extensions of positioning and stabilizing structure 9600. Positioning and stabilizing structure 9600 may be fixedly or releasably connectable at opposing lateral edges 9295 / 9290 of the eye mask 9000 with sleeves 9650 connected partially or fully along their length to the lateral and / or inferior walls or edges of face-contacting structure 9020.Sleeves 9650 may be connected or formed with positioning and stabilizing device 9600 at closed sleeve end 9652 distal from a bridge portion 7420, with an opposing terminal sleeve end 9653 configured with a sleeve opening 9651 for receiving rigidiser arm 3302 of frame portion 3307.In use, rigidiser arms 3302 are inserted within sleeves 9650 until the ends of the rigidiser arms 3302 proximate the frame body 3310 abut the terminal sleeve ends9653 of sleeves 9650. To retain rigidiser arms 3302 within sleeves 9650, sleeves 9650 may comprise a second opening in the form of a slit or buttonhole 9658 configured to receive a protrusion formed within the frame portion 3307, such that when the protrusion is received within the slit or buttonhole 9658, the nasal cradle is fixed in position for effective use as part of an RPT system, with air conduit 3361 extending anteriorly from the frame body 3310, ready for connection to an air supply of an RPT system. In some embodiments, terminal sleeve ends 9653 may be unattached to the eye component or face-contacting structure, such that the terminal sleeve ends can move flexibly around the rigidiser arms, and allow for some movement and / or adjustment of the patient interface by the user, when in use.FIG. 14C shows the eye mask 0900 with nasal cradle cushion assembly in an in-use position, forming patient interface 10000. Rigidiser arms 3302 are fully inserted within sleeves 9650 through openings 9651, and cushion assembly 3150 and frame body 3310 are positioned and held between the opposing terminal sleeve ends 9653. The use of the nasal cradle design creates, when in the in-use position, a space 9405 that may be covered by a cover member 3400 (FIG. 14A).4.9 GLOSSARY

[0519] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.4.9.1 Anatomy4.9.1.1 Anatomy of the face

[0520] Ala: the external outer wall or "wing" of each nostril (plural: alar)

[0521] Alar angle: An angle formed between the ala of each nostril.

[0522] Alare: The most lateral point on the nasal ala.

[0523] Alar curvature (or alar crest) point: The most posterior point in the curved base line of each ala, found in the crease formed by the union of the ala with the cheek.

[0524] Auricle: The whole external visible part of the ear.

[0525] (nose) Bony framework: The bony framework of the nose comprises the nasal bones, the frontal process of the maxillae and the nasal part of the frontal bone.

[0526] (nose) Cartilaginous framework: The cartilaginous framework of the nose comprises the septal, lateral, major and minor cartilages.

[0527] Columella: the strip of skin that separates the nares and which runs from the pronasale to the upper lip.

[0528] Columella angle: The angle between the line drawn through the midpoint of the nostril aperture and a line drawn perpendicular to the Frankfort horizontal while intersecting subnasale.

[0529] Frankfort horizontal plane: A line extending from the most inferior point of the orbital margin to the left tragion. The tragi on is the deepest point in the notch superior to the tragus of the auricle.

[0530] Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0531] Lateral nasal cartilage: A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.

[0532] Lip, lower (labrale inferius): The lip extending between the subnasale and the mouth.

[0533] Lip, upper (labrale superius): The lip extending between the mouth and the supramenton.

[0534] Greater alar cartilage: A plate of cartilage lying below the lateral nasal cartilage. It is curved around the anterior part of the naris. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four minor cartilages of the ala.

[0535] Nares (Nostrils): Approximately ellipsoidal apertures forming the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nares are separated by the nasal septum.

[0536] Naso-labial sulcus or Naso-labial fold: The skin fold or groove that runs from each side of the nose to the comers of the mouth, separating the cheeks from the upper lip.

[0537] Naso-labial angle: The angle between the columella and the upper lip, while intersecting subnasale.

[0538] Otobasion inferior: The lowest point of attachment of the auricle to the skin of the face.

[0539] Otobasion superior: The highest point of attachment of the auricle to the skin of the face.

[0540] Pronasale: the most protruded point or tip of the nose, which can be identified in lateral view of the rest of the portion of the head.

[0541] Philtrum: the midline groove that runs from lower border of the nasal septum to the top of the lip in the upper lip region.

[0542] Pogonion: Located on the soft tissue, the most anterior midpoint of the chin.

[0543] Ridge (nasal): The nasal ridge is the midline prominence of the nose, extending from the Sellion to the Pronasale.

[0544] Sagittal plane: A vertical plane that passes from anterior (front) to posterior (rear). The midsagittal plane is a sagittal plane that divides the body into right and left halves.

[0545] Sellion: Located on the soft tissue, the most concave point overlying the area of the frontonasal suture.

[0546] Septal cartilage (nasal): The nasal septal cartilage forms part of the septum and divides the front part of the nasal cavity.

[0547] Subalare: The point at the lower margin of the alar base, where the alar base joins with the skin of the superior (upper) lip.

[0548] Subnasal point: Located on the soft tissue, the point at which the columella merges with the upper lip in the midsagittal plane.

[0549] Supramenton: The point of greatest concavity in the midline of the lower lip between labrale inferius and soft tissue pogonion4.9.1.2 Anatomy of the skull

[0550] Frontal bone: The frontal bone includes a large vertical portion, the squama frontalis, corresponding to the region known as the forehead.

[0551] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0552] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upwards by the side of the nose, and forms part of its lateral boundary.

[0553] Nasal bones: The nasal bones are two small oblong bones, varying in size and form in different individuals; they are placed side by side at the middle and upper part of the face, and form, by their junction, the "bridge" of the nose.

[0554] Nasion: The intersection of the frontal bone and the two nasal bones, a depressed area directly between the eyes and superior to the bridge of the nose.

[0555] Occipital bone: The occipital bone is situated at the back and lower part of the cranium. It includes an oval aperture, the foramen magnum, through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0556] Orbit: The bony cavity in the skull to contain the eyeball.

[0557] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the cranium.

[0558] Temporal bones: The temporal bones are situated on the bases and sides of the skull, and support that part of the face known as the temple.

[0559] Zygomatic bones: The face includes two zygomatic bones, located in the upper and lateral parts of the face and forming the prominence of the cheek.4.9.2 Patient interface

[0560] Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.

[0561] Headgear: Headgear will be taken to mean a form of positioning and stabilising structure designed to hold a device, e.g., an eye mask, on a head.

[0562] Plenum chamber: a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.

[0563] Seal: May be a noun form ("a seal") which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and / or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.&Second side wall portion 30217tooConnection structures 9888&4.11 OTHER REMARKS

[0564] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0565] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independentlyincluded in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0566] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0567] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0568] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0569] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0570] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents, unless the context clearly dictates otherwise.

[0571] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publicationprovided may be different from the actual publication dates, which may need to be independently confirmed.

[0572] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0573] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0574] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0575] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.

Claims

CLAIMS1. An eye mask configured for use with a respiratory pressure therapy (RPT) system, comprising:an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and an opposing posterior surface;a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user;a positioning and stabilising structure configured to provide a force to hold the eye component of the eye mask in an in-use position on a user’s head during use of the eye mask; anda connection structure configured to directly or indirectly fluidly connect with an air circuit of a respiratory pressure therapy system or component thereof.

2. The eye mask of claim 1, wherein the eye mask comprises a face-contacting structure connected to the posterior surface of the eye component, the facecontacting structure comprising a user-facing surface on a user-facing side of the face-contacting structure and the cavity is formed within the user-facing surface for the face contacting structure.

3. The eye mask of claim 1 or claim 2, wherein the cavity perimeter is defined or partially defined by a wall extending at least from a base portion of the cavity to the user-facing surface of the face-contacting structure.

4. The eye mask of claim 3, wherein the wall extends continuously around superior, lateral and inferior boundaries of the cavity.

5. The eye mask of claim 3, wherein the wall extends around superior and lateral boundaries of the cavity and at least partially around an inferior boundary of the cavity.

6. The eye mask of any one of claims 3 to 5, wherein the wall comprises a first side wall portion extending from a perimeter of the base portion of the cavity tothe user-facing surface of the face-contacting structure, and a second side-wall portion opposing and spaced apart from the first side wall portion closer to the perimeter of the eye mask than the first side wall portion and extending towards the user-facing surface, the first and second side wall portions spanned by a userfacing surface wall portion.

7. The eye mask of claim 6, wherein the second side-wall portion of the wall forms a portion of a perimeter of the eye mask.

8. The eye mask of any one of claims 3 to 7, wherein the wall comprises a superior raised wall section extending laterally along a superior edge of the cavity, proximate to, or on a superior edge of the eye mask.

9. The eye mask of any one of claims 3 to 8, wherein the wall comprises an inferior raised wall section extending along or partially along an inferior edge of the cavity, and / or proximate to, or on the inferior edge of the eye mask.

10. The eye mask of any one of claims 3 to 9, wherein the eye mask comprises an inferior raised wall section extending along or partially along an inferior edge of the cavity, and / or proximate to, or on the inferior edge of the eye mask, and a superior raised wall section extending laterally along a superior edge of the cavity, proximate to, or on a superior edge of the eye mask.

11. The eye mask of claim 10, wherein the superior and inferior raised wall sections are connected by opposing lateral edge wall sections to define a perimeter of the cavity.

12. The eye mask of claim 8, wherein the superior raised wall section comprises a first side wall portion and a second side wall portion opposing the first side wall portion, the first and second side wall portions spanned by a user-facing surface wall portion.

13. The eye mask of claim 9, wherein the inferior raised wall section comprises a first side wall portion and a second side wall portion opposing the first side wall portion, the first and second side wall portions spanned by a user-facing surface wall portion.

14. The eye mask of claim 10, wherein the superior raised wall section is configured such that the user-facing surface wall portion of the superior raised wall section is a greater distance from a base portion of the cavity than the userfacing surface wall portion of the inferior raised wall section.

15. The eye mask of any one of claims 8, 12 or 14, wherein the superior raised wall section is sized to substantially traverse at least between left and right supraorbital foramen and / or span the central region of the frontal bone of a user’s head in use.

16. The eye mask of claim 12, wherein the first side wall portion and / or a second side wall portion of the superior raised wall section are variable in height along a length of the superior raised wall section.

17. The eye mask of claim 13, wherein the first side wall portion and / or a second side wall portion of the inferior raised wall section are variable in height along a length of the inferior raised wall section.

18. An eye mask configured for use with a respiratory pressure therapy (RPT) system, comprising:- an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface;- a face-contacting structure connected to the posterior surface of the eye component, the face-contacting structure comprising a user-facing surface on a user-facing side of the face-contacting structure, a recess, and a cavity formed within the user-facing surface, a perimeter of each of the recess and cavity defined or partially defined by a wall extending at least from a base portion of each of the recess and cavity to the user-facing surface;- a functional module removably housed within the recess;- a positioning and stabilising structure configured to provide a force to hold the eye component and face-contacting structure of the eye mask in an in-use position on the user’s head during use of the eye mask; and- a connection structure configured to be directly or indirectly fluidly connectable with an air circuit of a respiratory therapy system or component thereof.

19. The eye mask of claim 18, wherein the recess formed within the user-facing surface of the face-contacting structure is formed superior to the cavity.

20. The eye mask of claim 18 or 19, wherein the recess is sized to substantially traverse at least between left and right zygomatic regions of a user’s head in use.

21. The eye mask of any one of claims 18 -20, wherein the cavity is sized to substantially traverse the orbital regions of a user’s head in use.

22. The eye mask of any one of claims 18 - 21, wherein the wall extends at least partially around superior, lateral and inferior boundaries of the cavity and the recess.

23. The eye mask of claim 18, wherein the wall comprises a superior raised wall section extending laterally along a top edge of the recess, proximate a top edge of the eye mask, an intermediate raised wall section spaced apart from the superior raised wall section and extending laterally along an inferior edge of the recess and a superior edge of the cavity, and an inferior raised wall section extending along a bottom edge of the cavity, proximate the inferior edge of the eye mask.

24. The eye mask of claim 22, wherein each of the superior raised wall section, intermediate raised wall section and inferior raised wall sections comprise a first side wall portion and a second side wall portion opposing the first side wall portion, the first and second side wall portions spanned by a user-facing surface wall portion.

25. The eye mask of claim 22 or 23, wherein the superior raised wall section is more resiliently flexible than the intermediate or inferior raised wall sections.

26. The eye mask of claim 23, wherein the superior raised wall section extends from a base portion of the recess a greater distance than the intermediate raised wall section extends from the base portion of the recess, such that the user-facing surface wall portion of the superior raised wall section abuts the user’s face when the eye mask is in use.

27. The eye mask of any one of claims 22 - 26, wherein the superior and inferior raised wall sections are connected by opposing lateral edge wall sections to define a perimeter of the cavity.

28. The eye mask of claim 27, wherein the superior raised wall section, inferior raised wall sections and the lateral edge sections comprise compressive material.

29. The eye mask of claim 18, wherein the functional module comprises a convex side and a concave side, the concave side comprising a user-contacting layer comprising a textile, fabric composite, silicone pad, cushion region, fragrance delivery mechanism, sensor, cooling material, gripping material, massage component, light source or combination thereof.

30. The eye mask of any one of claims 3 - 29, wherein the eye mask comprises a bridge portion in the form of a curved wall along the inferior edge or part thereof of the eye mask.

31. The eye mask of claim 13 or 24, wherein the inferior raised wall section, face contacting structure and / or eye component curves around a anterior / posterior axis of the eye mask forming a bridge portion to accommodate a nasal bridge of a user.

32. The eye mask of claim 31, wherein the inferior raised wall section, face contacting structure and / or eye component that curves around the anterior / posterior axis of the eye mask defines an open space for accommodating a nose of the user or part thereof, the eye mask further comprising a cover member configured to span the open space, covering the user’s nose or part thereof.

33. The eye mask of claim 32, wherein the cover member is in the form of a flexible textile or foam component.

34. The eye mask of claim 31, wherein the bridge portion comprises a portion of the inferior raised wall section and the inferior raised wall section comprises at least one compressive region defined by the first side wall portion, second side wall portion, user-facing surface wall portion of the inferior raised wall section and a posterior surface of the eye component.

35. The eye mask of claim 34, wherein the at least one compressive region is an air-pocket.

36. The eye mask of any one of claims 1 to 35, wherein the connection structure is configured directly or indirectly receive a frame portion, the frame portion configured to be directly or indirectly connectable with an air circuit of a respiratory therapy system or component thereof.

37. The eye mask of claim 36, wherein the frame portion comprises a frame body and two or more rigi diser arms symmetrically disposed on opposite sides of the frame body.

38. The eye mask of claim 36 or 37, wherein the connection structure comprises at least one sleeve.

39. The eye mask of claim 38, wherein the connection structure comprises;two elongate sleeves formed at an inferior edge of the eye mask and / or wall, the two elongate sleeves formed within, or by, the face contacting structure and / or eye component and / or positioning and stabilising structure of the eye mask; andwherein each elongate sleeve forms and at least one opening to receive at least a portion of an arm of a frame portion configured to be fluidly connectable with an air circuit of a respiratory therapy system or component thereof.

40. The eye mask of claim 39, wherein each elongate sleeve comprises two openings, at least one of the two openings in the form of a buttonhole or slit.

41. The eye mask of claim 39 or 40, wherein the eye mask comprises a bridge portion configured as a curved wall centrally positioned along an inferior edge or part thereof of the eye mask and one each of the two elongate sleeves are located either side of the bridge portion.

42. The eye mask of claim 9 or 23, wherein the inferior raised wall section comprises two raised wall sections spaced apart along the inferior edge of the eye mask either side of a bridge portion, each raised wall section comprising therein, supporting, connected to or formed as an elongate sleeve.

43. The eye mask of claim 39, wherein the eye mask comprises a bridge portion and the at least one opening is formed in each elongate sleeve proximate the bridge portion of the eye mask.

44. The eye mask of any one of claims 39 - 41, wherein the two elongate sleeves are configured to releasably receive the rigidiser arms of the frame portion.

45. The eye mask of any one of claims 39-41, wherein the two elongate sleeves are each continuously formed with a portion of the positioning and stabilising structure of the eye mask.

46. A patient interface for use with a respiratory pressure therapy (RPT) system comprising:an eye mask as claimed in any one of claims 1 to 45;a frame portion comprising a frame body and two or more rigidiser arms symmetrically disposed on opposite sides of the frame body, the rigidiser arms configured to be releasably connected to the eye mask; anda cushion assembly comprising a seal forming structure, the cushion assembly configured to releasably connect to the frame portion; andthe frame portion and cushion assembly together configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof.

47. A patient interface for use with a respiratory pressure therapy (RPT) system comprising:an eye mask comprising:an eye component positionable over at least orbital regions of a face of a user and configured to block light to eyes of the user, the eye component having an anterior surface and opposing posterior surface;a cavity formed within the posterior surface of the eye component, the cavity positionable in use over the orbital regions of the face of the user;a connection structure configured to connect with a frame portion; anda positioning and stabilising structure constructed and arranged to provide an elastic force to hold the eye component of the eye mask in an in-use and therapeutically effective position on the user’s head during use of the RPT system;Illa frame portion comprising a frame body and two or more rigidiser arms symmetrically disposed on opposite sides of the frame body; anda cushion assembly comprising a seal forming structure, the cushion assembly configured to releasably connect to the frame portion; andthe frame portion and cushion assembly together forming a plenum chamber and each configured to be directly or indirectly fluidly and releasably connectable with an air circuit of a respiratory therapy system or component thereof.

48. The patient interface of claim 47, wherein each of the rigidiser arms comprises a distal free end distal from the frame body, and a proximate attached end proximate the frame body, each of the rigidiser arms comprising a protrusion at a proximate free end of each rigidiser arm, the protrusion configured to releasably connect to the connection structure of the eye mask.

49. The patient interface of any one of claims 47 - 48, wherein the connection structure of the eye mask comprises at least one sleeve formed by, on or within the eye component and / or positioning and stabilising structure of the patient interface.

50. The patient interface of claim 49, wherein the connection structure comprises two elongate sleeves formed at, in or on an inferior edge of the eye mask, each elongate sleeve forming at least one opening to receive at least a portion of one of the two or more rigidiser arms of the frame portion.

51. The patient interface of claim 50, wherein each at least one of the at least one openings is formed as a slit or buttonhole configured to releasably receive a protrusion on at least one of the two or more rigidiser arms and secure the rigidiser arm(s) in position within the elongate sleeves.

52. The patient interface of claim 50 or 51, wherein the eye mask comprises a bridge portion configured as a curved wall centrally positioned along an inferior edge or part thereof of the eye mask and one of each of the two elongate sleeves are located either side of the bridge portion.

53. The patient interface of claim 52, wherein the opening is formed in an end of each elongate sleeve proximate the bridge portion of the eye mask.

54. The patient interface of any one of claims 50 - 53, wherein each of the two elongate sleeves comprises two openings, at least one opening in the form of a buttonhole or slit.

55. The patient interface of any one of claims 47 to 54, wherein the rigidiser arms of the frame portion are configured to releasably connect with the positioning and stabilising member of the eye mask when received within or by the connection structure of the eye mask.

56. The patient interface of claim 52, wherein the bridge portion of the eye mask defines an open space for accommodating a nose of the user or part thereof, the eye mask comprising a cover member configured to span the open space, covering the user’ s nose or part thereof.

57. The patient interface of claim 56, wherein the cover member is in the form of a flexible textile or foam component.

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